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Role of Axumin PET Scan in Germ Cell Tumor (TESTPET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03426865
Recruitment Status : Completed
First Posted : February 8, 2018
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Aditya Bagrodia, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE January 25, 2018
First Posted Date  ICMJE February 8, 2018
Last Update Posted Date February 17, 2020
Actual Study Start Date  ICMJE March 1, 2018
Actual Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2018)
Performance characteristics of Axumin PET scan in patients undergoing retroperitoneal lymph node dissection [ Time Frame: Two years ]
Investigate the accuracy of anti-18F-FACBC PET/CT correlating with histopathologic outcomes
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Axumin PET Scan in Germ Cell Tumor
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
FDA approved tracer being assessed in a non-FDA approved disease.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Testis Cancer
  • Germ Cell Tumor
  • Testicular Cancer
  • Germ Cell Tumor of Testis
  • Germ Cell Tumor, Testicular, Childhood
  • Testicular Neoplasms
  • Testicular Germ Cell Tumor
  • Testicular Yolk Sac Tumor
  • Testicular Choriocarcinoma
  • Testicular Diseases
  • Germ Cell Cancer Metastatic
  • Germ Cell Neoplasm of Retroperitoneum
  • Germ Cell Cancer, Nos
Intervention  ICMJE Drug: Axumin PET scan
PET scan prior to RPLND
Other Name: PET SCAN ARM
Study Arms  ICMJE Experimental: Axumin PET scan
Only one arm is being evaluated--the arm receiving PET scan
Intervention: Drug: Axumin PET scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 30, 2019
Actual Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Males with germ cell tumors (testicular cancer)
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03426865
Other Study ID Numbers  ICMJE 032017-051
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aditya Bagrodia, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aditya Bagrodia, MD University of Texas Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP