Role of Axumin PET Scan in Germ Cell Tumor

NCT ID: NCT03426865

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2023-06-01

Brief Summary

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

Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Axumin PET scan

Only one arm is being evaluated--the arm receiving PET scan

Axumin PET scan

Intervention Type DRUG

PET scan prior to RPLND

Interventions

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Axumin PET scan

PET scan prior to RPLND

Intervention Type DRUG

Other Intervention Names

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PET SCAN ARM

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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yair lotan

Professor of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yair Lotan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STU 032017-051

Identifier Type: -

Identifier Source: org_study_id

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