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CompletedNCT03426865TESTPETUpdated Aug 11, 2025

Role of Axumin PET Scan in Germ Cell Tumor

An observational study in Testis Cancer, Germ Cell Tumor and Testicular Cancer, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by University of Texas Southwestern Medical Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
10 participants (actual)
Patient registry
No

Groups and cohorts

  • Axumin PET scan

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

    Drug: Axumin PET scan

Interventions

  • DrugAxumin PET scan

    PET scan prior to RPLND

    Also known as: PET SCAN ARM

05

What researchers measure

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

    Time frame: Two years

06

Study locations

1 site
  • UT Southwestern Medical Center
    Dallas, Texas 75390, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03426865
Lead sponsor
University of Texas Southwestern Medical Center
Responsible party
yair lotan (Professor of Urology, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Feb 8, 2018
Start date
Mar 1, 2018
Primary completion
Jun 1, 2023
Completion
Jun 1, 2023
Last update
Aug 11, 2025

Study contacts

Yair Lotan, MD
principal investigator · University of Texas Southwestern Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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