TESTPET: Role of Axumin PET Scan in Germ Cell Tumor

University of Texas Southwestern Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID

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.

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:
Actual Enrollment :
10 participants
Observational Model:
Time Perspective:
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:
  • Outcome Measures

    Primary Outcome Measures

    1. 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


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations


    Site City State Country Postal Code
    1 UT Southwestern Medical Center Dallas Texas United States 75390

    Sponsors and Collaborators

    • University of Texas Southwestern Medical Center


    • Principal Investigator: Yair Lotan, MD, University of Texas Southwestern Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Yair Lotan, Professor of Urology, University of Texas Southwestern Medical Center
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • STU 032017-051
    First Posted:
    Feb 8, 2018
    Last Update Posted:
    Nov 15, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by Yair Lotan, Professor of Urology, University of Texas Southwestern Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 15, 2021