Role of Axumin PET Scan in Germ Cell Tumor (TESTPET)

The University of Texas System (UT)

Status: Active, not recruiting

Conditions: Testicular Choriocarcinoma; Testicular Cancer; Germ Cell Cancer, Nos; Testicular Diseases; Germ Cell Neoplasm of Retroperitoneum; Testicular Neoplasms; Germ Cell Cancer Metastatic; Testis Cancer; Germ Cell Tumor; Germ Cell Tumor of Testis; Testicular Yolk Sac Tumor; Germ Cell Tumor, Testicular, Childhood; Testicular Germ Cell Tumor

Treatments: Drug: Axumin PET scan

Study type: Observational

Funder types: Other

Identifiers

NCT03426865

STU 032017-051

Details and patient eligibility

About

Investigators will use Axumin PET/CT to help with the imaging modalities to determine the presence of occult retroperitoneal disease.

Full 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.

Enrollment: 10 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

Axumin PET scan

Description:

Only one arm is being evaluated--the arm receiving PET scan

Treatment:

Drug: Axumin PET scan