Role of Axumin PET Scan in Germ Cell Tumor

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Brief Title

Role of Axumin PET Scan in Germ Cell Tumor

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

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 Type

Observational


Primary Outcome

Performance characteristics of Axumin PET scan in patients undergoing retroperitoneal lymph node dissection


Condition

Testis Cancer

Intervention

Axumin PET scan

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

10

Start Date

March 1, 2018

Completion Date

December 30, 2019

Primary Completion Date

December 30, 2019

Eligibility Criteria

        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
      

Gender

Male

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Aditya Bagrodia, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03426865

Organization ID

STU 032017-051


Responsible Party

Principal Investigator

Study Sponsor

University of Texas Southwestern Medical Center


Study Sponsor

Aditya Bagrodia, MD, Principal Investigator, University of Texas Southwestern Medical Center


Verification Date

April 2021