Testis CancerTESTPETNCT03426865
Role of Axumin PET Scan in Germ Cell Tumor
An observational study of Testis Cancer and Germ Cell Tumor, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Investigators will use Axumin PET/CT to help with the imaging modalities to determine the presence of occult retroperitoneal disease. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Testis Cancer, Germ Cell Tumor, Testicular Cancer
- What is being tested?
- Axumin PET scan
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Population will be selected from patients seen in the clinic at University of Texas Southwestern Medical Center
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Testis Cancer, Germ Cell Tumor, Testicular Cancer, Germ Cell Tumor of Testis, Germ Cell Tumor, Testicular, Childhood, Testicular Neoplasms
- Being tested
- Axumin PET scan
- Keywords
- retroperitoneal lymph node dissection, testicular cancer, testis cancer, germ cell tumor, PET scan, Axumin, teratoma
- Medical subject headings
- Testicular Neoplasms, Neoplasms, Germ Cell and Embryonal, Testicular Germ Cell Tumor, Endodermal Sinus Tumor, Testicular Diseases, Teratoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axumin PET scanDrug
Also called PET SCAN ARM
PET scan prior to RPLND
| Study group | Role | What they receive |
|---|---|---|
| Axumin PET scan | Only one arm is being evaluated--the arm receiving PET scan Receives: Drug: Axumin PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start1 Mar 2018
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testis CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yair lotan, University of Texas Southwestern Medical Center
- Investigators
- Yair Lotan, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426865
- Sponsor's protocol ID
- STU 032017-051
- Acronym
- TESTPET
- Status last verified
- Aug 2025
- First submitted
- 25 Jan 2018
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03426865
- Acronym / sponsor ID
- TESTPET / STU 032017-051
- Conditions
- Testis Cancer, Germ Cell Tumor, Testicular Cancer, Germ Cell Tumor of Testis, Germ Cell Tumor, Testicular, Childhood, Testicular Neoplasms
- Keywords
- retroperitoneal lymph node dissection, testicular cancer, testis cancer, germ cell tumor, PET scan, Axumin, teratoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 8 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators will use Axumin PET/CT to help with the imaging modalities to determine the presence of occult retroperitoneal disease.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axumin PET scan | – | Drug: Axumin PET scanOnly one arm is being evaluated--the arm receiving PET scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population will be selected from patients seen in the clinic at University of Texas Southwestern Medical Center
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axumin PET scanAlso: PET SCAN ARMPET scan prior to RPLND | Drug | Axumin PET scan |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yair Lotan, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testis Cancer and Germ Cell Tumor, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance characteristics of Axumin PET scan in patients undergoing retroperitoneal lymph node dissection (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.