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

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ClinicalTrials.gov Identifier: NCT03426865
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Aditya Bagrodia, University of Texas Southwestern Medical Center

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

Condition or disease Intervention/treatment Phase
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 Drug: Axumin PET scan Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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
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 : March 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : January 31, 2019


Arm Intervention/treatment
Experimental: Axumin PET scan
Only one arm is being evaluated--the arm receiving PET scan
Drug: Axumin PET scan
PET scan prior to RPLND
Other Name: PET SCAN ARM




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males with germ cell tumors (testicular cancer)
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426865


Contacts
Contact: Aditya Bagrodia, MD 214-645-8787 Aditya.Bagrodia@utsoutwestern.edu
Contact: Allison Beaver, RN, BSN 214-645-8787 Allison.Beaver@utsouthwestern.edu

Locations
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Aditya Bagrodia, MD    214-645-8787    Aditya.Bagrodia@utsouthwestern.edu   
Contact: Allison Beaver, RN, BSN    214-645-8787    Allison.Beaver@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Aditya Bagrodia, MD University of Texas Southwestern Medical Center

Responsible Party: Aditya Bagrodia, Assistant Professor of Urology, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03426865     History of Changes
Other Study ID Numbers: 032017-051
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aditya Bagrodia, University of Texas Southwestern Medical Center:
retroperitoneal lymph node dissection
testicular cancer
testis cancer
germ cell tumor
PET scan
Axumin
teratoma

Additional relevant MeSH terms:
Testicular Neoplasms
Neoplasms
Neoplasms, Germ Cell and Embryonal
Endodermal Sinus Tumor
Choriocarcinoma
Testicular Diseases
Retroperitoneal Neoplasms
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Gonadal Disorders
Mesonephroma
Trophoblastic Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Pregnancy Complications, Neoplastic
Pregnancy Complications
Abdominal Neoplasms