Germ Cell Cancer Metastatic, Germ Cell Cancer, Nos, Germ Cell Neoplasm of Retroperitoneum, Germ Cell Tumor, Germ Cell Tumor of Testis, Germ Cell Tumor, Testicular, Childhood, Testicular Cancer, Testicular Choriocarcinoma, Testicular Diseases, Testicular Germ Cell Tumor, Testicular Neoplasms, Testicular Yolk Sac Tumor, Testis Cancer
Conditions
Keywords
retroperitoneal lymph node dissection, testicular cancer, testis cancer, germ cell tumor, PET scan, Axumin, teratoma
Brief summary
Investigators will use Axumin PET/CT to help with the imaging modalities to determine the presence of occult retroperitoneal disease.
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.
Interventions
DRUGAxumin PET scan
PET scan prior to RPLND
Sponsors
University of Texas Southwestern Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed