Testicular Germ Cell Tumor Clinical Trial
— TESTPETOfficial title:
Anti-1-amino-3-18F-flurocyclobutane-1-carboxylic Acid (Axumin) Positron Emission Tomography/Computed Tomography Prior to Retroperitoneal Lymph Node Dissection for Testicular Cancer
Verified date | November 2023 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Investigators will use Axumin PET/CT to help with the imaging modalities to determine the presence of occult retroperitoneal disease.
Status | Active, not recruiting |
Enrollment | 10 |
Est. completion date | July 5, 2024 |
Est. primary completion date | July 5, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with histologically confirmed NSGCT after orchiectomy who are scheduled to undergo primary RPLND or post-chemotherapy RPLND - Patients must be over 18 years old and capable and willing to provide informed consent. - Medically stable as judged by patient's physician. - Life expectancy must be estimated at > 6 months. - 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: - Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals of similar chemical or biologic composition to anti-18F-FACBC are NOT eligible. - Patients with liver failure are NOT eligible. - Patients currently undergoing chemotherapy or chemotherapy within two weeks of anti-18F-FACBC PET/CT scan are NOT eligible |
Country | Name | City | State |
---|---|---|---|
United States | UT Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Performance characteristics of Axumin PET scan in patients undergoing retroperitoneal lymph node dissection | Investigate the accuracy of anti-18F-FACBC PET/CT correlating with histopathologic outcomes | Two years |
Status | Clinical Trial | Phase | |
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