Role of Axumin PET Scan in Germ Cell Tumor

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

Detailed Description
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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.

Official Title
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Anti-1-amino-3-18F-flurocyclobutane-1-carboxylic Acid (Axumin) Positron Emission Tomography/Computed Tomography Prior to Retroperitoneal Lymph Node Dissection for Testicular Cancer

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

Intervention / Treatment
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* Drug: Axumin PET scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Axumin PET scan<br>Only one arm is being evaluated--the arm receiving PET scan | Drug: Axumin PET scan<br>* PET scan prior to RPLND<br>* Other names: PET SCAN ARM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Axumin, retroperitoneal lymph node dissection, testicular cancer, testis cancer, germ cell tumor, PET scan, teratoma