TelixU Medical Education - Reader Training

Module 1 - Part One: The Basics of ⁶⁸Ga PSMA-11 PET/CT

Presented by: Nat Lenzo, MMed, MSc(Oncol)

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This PSMA Reader Training Module 1 | Part One provides a basic understanding of the clinical applications of ⁶⁸Ga PSMA-11 PET/CT scans; develops skills to effectively read ⁶⁸Ga PSMA-11 PET/CT scans, reviews the process for reading scans, provides the basis for implementing scanning protocols for ⁶⁸Ga PSMA-11 PET/CT, and specifies when to order ⁶⁸GAa PSMA-11.

Teaching Points

Provides an overview of ⁶⁸Ga PSMA-11 PET Imaging.
Reviews a number of publications demonstrating clinical efficacy, safety, and experience of ⁶⁸Ga PSMA-11.
Describes the differences of ⁶⁸Ga PSMA-11 from other PET Tracers (FDG, Choline, Fluciclovine).
Compares PET/CT imaging with other imaging modalities (Bone Scan, MRI, CT).
Demonstrates the clinical impact of ⁶⁸Ga PSMA-11 PET/CT in clinical staging and management of Prostate cancer.
Improves reader confidence through comprehensive case study reviews of ⁶⁸Ga PSMA-11 PET/CT reading, interpretation, and clinical utility.

Note: “Test Your Knowledge” competency measurements in the form of quiz questions, will be displayed throughout the module.

Meet the Faculty

Nat Lenzo, M.D.
Clinical Director of Theranostics and Molecular Imaging
Genesis Care

Dr. Lenzo graduated in medicine from the University of Western Australia and completed a fellowship in nuclear medicine at the University of Michigan. Apart from undergraduate science, research, and medical degrees, he also holds master’s degrees in medicine, oncology, health service management and business administration. Dr Lenzo has authored more than 200 publications including over 50 scientific papers in international peer-reviewed journals (H index 21).

In 2015, Dr. Lenzo founded Theranostics Australia, now fully owned by GenesisCare, where he remains in the position of group clinical director. He is committed to expanding the field of theranostics with GenesisCare in Australia and overseas.

Module 1 - Part Two: The Basics of ⁶⁸Ga PSMA-11 PET/CT

Presented by: Nat Lenzo, MMed, MSc(Oncol)

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This PSMA Reader Training Module 1 | Part Two is a continuation of Part One. Part two provides additional basic learning and understanding of the clinical applications of ⁶⁸Ga PSMA-11 PET/CT scans; develops skills to effectively read ⁶⁸Ga PSMA-11 PET/CT scans, reviews the process for reading scans, provides the basis for implementing scanning protocols for ⁶⁸Ga PSMA-11 PET/CT, and specifies when to order ⁶⁸Ga PSMA-11.

Teaching Points

Provides an overview of ⁶⁸Ga PSMA-11 PET Imaging.
Reviews a number of publications demonstrating clinical efficacy, safety, and experience of ⁶⁸Ga PSMA-11.
Describes the differences of ⁶⁸Ga PSMA-11 from other PET Tracers (FDG, Choline, Fluciclovine).
Compares PET/CT imaging with other imaging modalities (Bone Scan, MRI, CT).
Demonstrates the clinical impact of ⁶⁸Ga PSMA-11 PET/CT in clinical staging and management of Prostate cancer.
Improves reader confidence through comprehensive case study reviews of ⁶⁸Ga PSMA-11 PET/CT reading, interpretation, and clinical utility.

Note: “Test Your Knowledge” competency measurements in the form of quiz questions, will be displayed throughout the module.

Module 2 - Considerations for ⁶⁸Ga-PSMA-11 PET/CT Imaging Interpretation

Presented by: Jaideep Sohi, MD

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This PSMA Reader Training module is designed to improve PSMA PET/CT reader skills and increase the reader’s confidence by reviewing; the PSMA expression scoring, providing an understanding of how ⁶⁸GA PSMA-11 varies from other PET Tracers (FDG, Choline, Fluciclovine), determining normal vs abnormal findings, explaining tips to navigate challenging ⁶⁸GA PSMA-11 PET/CT cases, and developing the consultative role of the interpreting physician.

Teaching Points

Implement ⁶⁸Ga-PSMA-11 PET/CT Imaging Interpretation Skills
Understand the Biodistribution of ⁶⁸Ga-PSMA-11 PET/CT
Review ⁶⁸Ga-PSMA-11 PET/CT Case Studies with Teaching Points
Develop the Consultative Role of the Interpreting Physician
Follow a Consistent Reading Format
- Review attenuation corrected and non-attenuation corrected PET images to look for artifacts and to confirm finding.
- Correlate with relevant prior imaging studies such as bone scans, CT, and MRIs etc.
- Review PET imaging in narrow and wide windowing to evaluate lesions involving/adjacent to tissues with high background activity.

Note: Competency measurements in the form of a short online knowledge assessment exam, will be presented upon completion.

Meet the Faculty

Jaideep S. Sohi, M.D.
President and Founder
American Molecular Imaging

Dr. Jaideep S. Sohi completed his residency training at one of the nation’s top-rated programs at the University of Iowa, where he also served as Chief Resident. Following residency, he completed a prestigious one-year PET/CT Fellowship at Johns Hopkins University

With over 15 years of high-level experience in the fields of PET/CT, diagnostic and therapeutic nuclear medicine, Dr. Sohi is passionate about working closely with referring providers and patients to provide exceptional quality of care. At the same time, he is actively involved in educating his colleagues regarding new imaging tracers by engaging in comprehensive clinical outreach programs.

Dr. Sohi currently serves as the president of American Molecular Imaging, as well as assistant professor of nuclear medicine at the California Northstate University School of Medicine.

Module 3 - Part One: Advanced Reading Skills: A Comprehensive PSMA-11 PET/CT Case Study Review

Presented by: Stefano Fanti, MD | Andrea Farolfi, MD

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Part 1 of this PSMA Reader Training module is designed assist the reader in reading PSMA PET/CT with confidence by navigating challenging cases, addressing pitfalls, providing clear direction for patient management in the PSMA PET/CT report, and developing skills to become a consultant to the referring physician(s).

Teaching Points

Increase the PSMA PET/CT reader’s skill through a comprehensive case study review of interesting cases.
Establish a methodical approach to reviewing image findings of PSMA PET/CT scans.
Develop a concise PSMA PET report.
Review 10 case study examples that demonstrate the clinical utility of ⁶⁸Ga PSMA-11 PET/CT and improve reader confidence.

Note: “Test Your Knowledge” competency measurements in the form of quiz questions, will be displayed throughout the module.

Meet the Faculty

Stefano Fanti, M.D.
Full Professor, Diagnostic Imaging at University of Bologna,
Director, Nuclear Medicine Division and PET Center, The Policlinico S. Orsola
Director, Specialty School of Nuclear Medicine, University of Bologna, Bologna, Italy

Dr. Fanti’s fields of interest include PET/CT imaging in oncology, innovative PET tracer development. Dr. Fanti has authored more than 1000 publications, including 520 original papers in international peer-reviewed journals, more than 700 abstracts, 30 books or chapters; H-index = 65; and has been an invited speaker in more than 120 international meetings.

Andrea Farolfi, M.D.
Division of Nuclear Medicine,
S. Orsola Hospital,
IRCCS Azienda Ospedaliero-Universitaria
Bologna, Italy

Dr. Farolfi graduated the University of Bologna in 2014 and began work in 2016 at the PET Unit at S.Orsola Policlinic Hospital, IRCCS Azienda Ospedaliero-Universitaria di Bologna. He is actively involved in both clinical routine and research area, with a particular interest for prostate cancer imaging. He is a full-time permanent nuclear medicine physician in the Division of Nuclear Medicine and has authored 24 scientific papers indexed on Scopus. H-index of 8 on Google Scholar, 6 on Scopus and has been an invited lecturer at more than 10 national and international meetings.

Module 3 - Part Two: Advanced Reading Skills: A Comprehensive PSMA-11 PET/CT Case Study Review

Presented by: Stefano Fanti, MD | Andrea Farolfi, MD

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Part 2 of this PSMA Reader Training module is a continuation of Part 1 and designed to assist the reader in reading PSMA PET/CT with confidence by navigating challenging cases, addressing pitfalls, providing clear direction for patient management in the PSMA PET/CT report, and developing skills to become a consultant to the referring physician(s).

Teaching Points

Increase the PSMA PET/CT reader’s skill through a comprehensive case study review of complicated cases.
Address pitfalls that may occur when navigating challenging cases.
Develop a comprehensive and concise PSMA PET report to support the management of disease
Review 10 case study examples that demonstrate the clinical utility of ⁶⁸Ga PSMA-11 PET/CT and improve reader confidence.

Note: “Test Your Knowledge” competency measurements in the form of quiz questions, will be displayed throughout the module.

Module 3 - Part Three: Advanced Reading Skills: A Comprehensive PSMA-11 PET/CT Case Study Review

Presented by: Stefano Fanti, MD | Andrea Farolfi, MD

View Program

Part 3 of this PSMA Reader Training module is a continuation of this program and is designed assist the reader in reading PSMA PET/CT with confidence, navigating challenging cases, addressing pitfalls, providing clear direction for patient management in the PSMA PET/CT report, and developing skills to become a consultant to the referring physician(s).

Teaching Points

Increase the PSMA PET/CT reader’s skill through a comprehensive case study review of advanced disease and unusual pathology.
Improve confidence of the findings through a determined review of the patient’s history and medical record, which support the need for a ⁶⁸Ga PSMA-11 PET/CT scan.
Navigate challenging cases and develop a concise PSMA PET report.
Review 13 case study examples that demonstrate the clinical utility of ⁶⁸Ga PSMA-11 PET/CT and improve reader confidence.

Note: “Test Your Knowledge” competency measurements in the form of quiz questions, will be displayed throughout the module.

Indications and Usage

Illuccix^®, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

with suspected metastasis who are candidates for initial definitive therapy
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

Important Safety Information

WARNINGS AND PRECAUTIONS

Risk for Misdiagnosis
Image interpretation errors can occur with gallium Ga 68 gozetotide PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of gallium Ga 68 gozetotide for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of gallium Ga 68 gozetotide for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Indications and Usage

Illuccix^®, ILLUCCIX, after radiolabeling with Ga 68, is for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

with suspected metastasis who are candidates for initial definitive therapy
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
For selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated

Important Safety Information

WARNINGS AND PRECAUTIONS

Risk for Misinterpretation
Image interpretation errors can occur with ILLUCCIX PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Imaging Prior to Initial Definitive or Suspected Recurrence Therapy
The performance of ILLUCCIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of ILLUCCIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.

Imaging to Select Patients for Lutetium Lu 177 Vipivotide Tetraxetan Therapy
The interpretation of ILLUCCIX PET may differ depending on imaging readers. ILLUCCIX PET interpretations to select patients for lutetium Lu 177 vipivotide tetraxetan therapy may be more consistent when judging gallium Ga 68 gozetotide uptake in any one tumor lesion compared to judging uptake for all lesions larger than size criteria. Multidisciplinary consultation to select patients for lutetium Lu 177 vipivotide tetraxetan therapy is recommended, particularly for ILLUCCIX imaging that a single reader finds borderline or difficult to interpret, or when patient eligibility hinges only on judgment of gallium Ga 68 gozetotide uptake for all lesions larger than size criteria.

Radiation Risks
Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.

ADVERSE REACTIONS

The safety of gallium Ga 68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMA-BCR studies, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

In the VISION study, 1003 patients received one dose of gallium Ga 68 gozetotide intravenously with the amount of radioactivity 167.1 ± 23.1 MBq (4.52 ± 0.62 mCi). Adverse reactions occurring at ≥0.5% in patients with metastatic prostate cancer who received gallium Ga 68 gozetotide injection in the clinical study were fatigue (1.2%), nausea (0.8%), constipation (0.5%), and vomiting (0.5%).

Adverse reactions occurring at a rate of < 0.5% in the VISION study were diarrhea, dry mouth, injection site reactions, including injection site hematoma and injection site warmth and chills.

DRUG INTERACTIONS

Androgen deprivation therapy and other therapies targeting the androgen pathway

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.

You are encouraged to report suspected adverse reactions of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com.

Please note that this information is not comprehensive.

Please see  full Prescribing Information.

References: 1. Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) prescribing information. 2. Griffeth LK. Use of PET/CT scanning in cancer patients: technical and practical considerations. Proc (Bayl Univ Med Cent). 2005;18(4):321-330. 3. Dorff TB, Fanti S, Farolfi A, Reiter RE, Sadun TY, Sartor O. The evolving role of prostate-specific membrane antigen-based diagnostics and therapeutics in prostate cancer. Am Soc Clin Oncol Educ Book. 2019;39:321-330. 4. Velikyan I. 68Ga-based radiopharmaceuticals: production and application relationship. Molecules. 2015;20(7):12913-12943. 5. Massat MB. Nuclear medicine prepares for greater 68Ga demand. Appl Radiol. 2021;50(2):30-31. https://appliedradiology.com/articles/nuclear-medicine-prepares-for-greater-ga-68-demand. Accessed May 13, 2022. 6. ARTMS and Telix Pharmaceuticals announce successful production of PSMA-11 with cyclotron produced 68Ga from a solid target [news release]. Telix Pharmaceuticals; January 12, 2021. https://telixpharma.com/news-media/artms-and-telix-pharmaceuticals-announce-successful-production-of-68ga-psma-11-with-cyclotron-produced-68ga-from-a-solid-target/. Accessed May 13, 2022. 7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Prostate Cancer V.4.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed May 12, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 8. Jadvar H, Calais J, Fanti S, et al. Appropriate use criteria for prostate-specific membrane antigen PET imaging. J Nucl Med. 2022;63(1):59-68. 9. Eiber M, Fendler WP, Rowe SP, et al. Prostate-specific membrane antigen ligands for imaging and therapy. J Nucl Med. 2017;58(suppl 2):67S-76S. 10. Ristau BT, O’Keefe DS, Bacich DJ. The prostate-specific membrane antigen: lessons and current clinical implications from 20 years of research. Urol Oncol. 2014;32(3):272-279. 11. Maurer T, Gschwend JE, Rauscher I, et al. Diagnostic efficacy of (68)Gallium-PSMA positron emission tomography compared to conventional imaging for lymph node staging of 130 consecutive patients with intermediate to high risk prostate cancer. J Urol. 2016;195(5):1436-1443.