ClinicalTrials.gg
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.

Primary conditionTesticular Germ Cell TumorRegistry: Testicular NeoplasmsReclassifiedWhy we changed it
Registry
Testicular Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Testicular Germ Cell Tumor
Why
  1. The study's listed conditions name Testicular Germ Cell Tumor, a narrower term within Testicular Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

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

In context

Testicular Germ Cell Tumor Reclassified

85 studies on the registry are indexed under Testicular Germ Cell Tumor; 10 are open to participants now.

This study's enrollment of 10 is below the median of 90 across 15 observational studies indexed under Testicular Germ Cell Tumor.

Browse Testicular Germ Cell Tumor studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.

Compared within Testicular Germ Cell Tumor, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Testicular Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with 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 .
  • Medically stable as judged by patient's physician.
  • must be estimated at > 6 months.
  • Patients must have an 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 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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

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

06

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

07

Study locations

1 site
  • UT Southwestern Medical Center
    Dallas, Texas 75390, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in Jun 2023, 63 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 25, 2018
First posted
Feb 8, 2018
StartActual
Mar 1, 2018
Primary completionActual
Jun 1, 2023
CompletionActual
Jun 1, 2023
Last update
Aug 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03426865
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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