Role of Axumin PET Scan in Germ Cell Tumor

NCT03426865 | Completed DMC FDA Drug

• 1 other identifier: STU 032017-051
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

retroperitoneal lymph node dissection; testicular cancer; testis cancer; germ cell tumor; PET scan; Axumin; teratoma

Outcome Measures

Primary Outcomes (1)

• Performance characteristics of Axumin PET scan in patients undergoing retroperitoneal lymph node dissection

  Investigate the accuracy of anti-18F-FACBC PET/CT correlating with histopathologic outcomes

  Two years

Study Arms (1)

Axumin PET scan

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

Drug: Axumin PET scan

Interventions

Axumin PET scan DRUG

PET scan prior to RPLND

Also known as: PET SCAN ARM

Axumin PET scan

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males with germ cell tumors (testicular cancer)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Population will be selected from patients seen in the clinic at University of Texas Southwestern Medical Center

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Testicular Neoplasms; Neoplasms, Germ Cell and Embryonal; Testicular Germ Cell Tumor; Endodermal Sinus Tumor; Testicular Diseases; Teratoma

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms by Histologic Type; Mesonephroma

Study Officials

• Yair Lotan, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 8, 2018
• Study Start: March 1, 2018
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)