TESTPET: Role of Axumin PET Scan in Germ Cell Tumor
Study Details
Study Description
Brief Summary
Investigators will use Axumin PET/CT to help with the imaging modalities to determine the presence of occult retroperitoneal disease.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Investigators aim to perform a prospective study of anti-18F-FACBC PET/CT in patients with NSGCT prior to RPLND, either in the primary setting or in the post-chemotherapy setting. We will correlate histopathologic outcomes from the RPLND specimen and clinical outcomes of recurrence during follow-up to identify the accuracy of anti-18F-FACBC PET/CT in these settings.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Axumin PET scan Only one arm is being evaluated--the arm receiving PET scan |
Drug: Axumin PET scan
PET scan prior to RPLND
Other Names:
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Outcome Measures
Primary Outcome Measures
- Performance characteristics of Axumin PET scan in patients undergoing retroperitoneal lymph node dissection [Two years]
Investigate the accuracy of anti-18F-FACBC PET/CT correlating with histopathologic outcomes
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with histologically confirmed NSGCT after orchiectomy who are scheduled to undergo primary RPLND or post-chemotherapy RPLND
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Patients must be over 18 years old and capable and willing to provide informed consent.
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Medically stable as judged by patient's physician.
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Life expectancy must be estimated at > 6 months.
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Patients must have an ECOG performance status of 0-3 (restricted to ECOG PS 0-2 if age
70 years).
- Patient must be able to lie still for a 20 to 30 minute PET/CT scan. Patients will be asked if they have problems or issues with lying flat
Exclusion Criteria:
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Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals of similar chemical or biologic composition to anti-18F-FACBC are NOT eligible.
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Patients with liver failure are NOT eligible.
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Patients currently undergoing chemotherapy or chemotherapy within two weeks of anti-18F-FACBC PET/CT scan are NOT eligible
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | UT Southwestern Medical Center | Dallas | Texas | United States | 75390 |
Sponsors and Collaborators
- University of Texas Southwestern Medical Center
Investigators
- Principal Investigator: Yair Lotan, MD, University of Texas Southwestern Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU 032017-051