Role of Axumin PET Scan in Germ Cell Tumor

Active, not recruiting

• Conditions: Testicular Cancer; Germ Cell Tumor; Testicular Germ Cell Tumor; Germ Cell Cancer Metastatic; Germ Cell Neoplasm of Retroperitoneum; Germ Cell Tumor, Testicular, Childhood; Testicular Choriocarcinoma; Germ Cell Tumor of Testis; Testicular Diseases; Testis Cancer
• Interventions: Drug: Axumin PET scan

• Registration Number: NCT03426865
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study First Submitted: 2018-01-25
• Study First Submitted QC: 2018-02-07
• Study First Posted: 2018-02-08
• Study Start: 2018-03-01
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-07-05
• Study Completion: 2026-07-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Axumin PET scan	Axumin PET scan	Only one arm is being evaluated--the arm receiving PET scan

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States