TESTPET: Role of Axumin PET Scan in Germ Cell Tumor

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03426865

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

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
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	Drug: Axumin PET scan

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

Study Type:

Observational

Actual Enrollment :

10 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official 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

Actual Study Start Date :

Mar 1, 2018

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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: PET SCAN ARM

Arm

Intervention/Treatment

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:

PET SCAN ARM

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

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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