- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03426865
Role of Axumin PET Scan in Germ Cell Tumor (TESTPET)
November 2, 2023 updated by: yair lotan, University of Texas Southwestern Medical Center
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.
Study Overview
Status
Active, not recruiting
Conditions
- Testicular Germ Cell Tumor
- Testicular Neoplasms
- Testicular Diseases
- Testis Cancer
- Testicular Cancer
- Germ Cell Tumor
- Testicular Yolk Sac Tumor
- Testicular Choriocarcinoma
- Germ Cell Tumor of Testis
- Germ Cell Tumor, Testicular, Childhood
- Germ Cell Cancer Metastatic
- Germ Cell Neoplasm of Retroperitoneum
- Germ Cell Cancer, Nos
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Dallas, Texas, United States, 75390
- UT Southwestern Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Axumin PET scan
Only one arm is being evaluated--the arm receiving PET scan
|
PET scan prior to RPLND
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yair Lotan, MD, University of Texas Southwestern Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2018
Primary Completion (Estimated)
July 5, 2024
Study Completion (Estimated)
July 5, 2024
Study Registration Dates
First Submitted
January 25, 2018
First Submitted That Met QC Criteria
February 7, 2018
First Posted (Actual)
February 8, 2018
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 2, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Urogenital Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Genital Neoplasms, Male
- Pregnancy Complications
- Abdominal Neoplasms
- Pregnancy Complications, Neoplastic
- Trophoblastic Neoplasms
- Mesonephroma
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Neoplasms
- Neoplasms, Germ Cell and Embryonal
- Testicular Neoplasms
- Choriocarcinoma
- Endodermal Sinus Tumor
- Testicular Diseases
- Retroperitoneal Neoplasms
Other Study ID Numbers
- STU 032017-051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Testicular Germ Cell Tumor
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N.N. Petrov National Medical Research Center of...RecruitingTesticular Germ Cell TumorRussian Federation
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Royal Marsden NHS Foundation TrustUniversity College London (UCL) Cancer InstituteUnknownTesticular Germ Cell TumorUnited Kingdom
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National Cancer Institute (NCI)TerminatedTesticular Seminoma | Recurrent Ovarian Germ Cell Tumor | Stage II Ovarian Germ Cell Tumor | Stage III Ovarian Germ Cell Tumor | Ovarian Dysgerminoma | Recurrent Malignant Testicular Germ Cell Tumor | Stage II Malignant Testicular Germ Cell Tumor | Stage III Malignant Testicular Germ Cell TumorUnited States
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Teratoma | Stage II Malignant Testicular Germ Cell Tumor | Stage III Malignant Testicular Germ Cell Tumor | Childhood Embryonal Tumor | Childhood Extracranial Germ Cell Tumor | Childhood Extragonadal Germ Cell Tumor | Childhood Malignant Ovarian Germ Cell Tumor | Childhood Malignant Testicular... and other conditionsUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedTesticular Seminoma | Testicular Yolk Sac Tumor | Childhood Malignant Ovarian Germ Cell Tumor | Childhood Malignant Testicular Germ Cell Tumor | Ovarian Embryonal Carcinoma | Ovarian Yolk Sac Tumor | Testicular Embryonal Carcinoma | Ovarian Choriocarcinoma | Ovarian Mixed Germ Cell Tumor | Testicular Choriocarcinoma and other conditionsUnited States
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European Organisation for Research and Treatment...UnknownTesticular Germ Cell Tumor | Teratoma | Extragonadal Germ Cell TumorFrance, Netherlands, Spain, United Kingdom, Norway, Belgium, Germany, Denmark, Hungary, Slovakia, Israel, Italy, Austria, Poland
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