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NCT03426865 Clinical Trial

Role of Axumin PET Scan in Germ Cell Tumor

Testicular Germ Cell Tumor Clinical Trial

— TESTPET  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03426865
Other study ID # STU 032017-051
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 1, 2018
Est. completion date July 5, 2024

Study information
Verified date November 2023
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 10
Est. completion date July 5, 2024
Est. primary completion date July 5, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Axumin PET scan
PET scan prior to RPLND

Locations
Country Name City State
United States UT Southwestern Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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