Role of Axumin PET Scan in Germ Cell Tu… | Clinical Trial

Key information

Conditions

Testis Cancer Endocrine Gland Neoplasms Endocrine System Diseases Endodermal Sinus Tumor Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Germ Cell Cancer Metastatic Germ Cell Cancer, Nos Germ Cell Neoplasm of Retroperitoneum Germ Cell Tumor Germ Cell Tumor of Testis Germ Cell Tumor, Testicular, Childhood Gonadal Disorders Male Urogenital Diseases Mesonephroma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Teratoma Testicular Cancer Testicular Choriocarcinoma Testicular Diseases Testicular Germ Cell Tumor Testicular Neoplasms Testicular Yolk Sac Tumor Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Axumin PET scan

Drug

PET scan prior to RPLND

Other names: PET SCAN ARM

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study 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

Acronym: TESTPET

Important dates

Study start: 2018
Primary completion: 2023
Study completion: 2023
First posted: Feb 8, 2018
Registry last updated: Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed