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, 2022
Primary Completion Date
December 30, 2022
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
Yair Lotan, 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
Yair Lotan, MD, Principal Investigator, University of Texas Southwestern Medical Center
Verification Date
November 2021