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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03426865




Registration number
NCT03426865
Ethics application status
Date submitted
25/01/2018
Date registered
8/02/2018

Titles & IDs
Public title
Role of Axumin PET Scan in Germ Cell Tumor
Scientific 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
Secondary ID [1] 0 0
STU 032017-051
Universal Trial Number (UTN)
Trial acronym
TESTPET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Testis Cancer 0 0
Germ Cell Tumor 0 0
Testicular Cancer 0 0
Germ Cell Tumor of Testis 0 0
Germ Cell Tumor, Testicular, Childhood 0 0
Testicular Neoplasms 0 0
Testicular Germ Cell Tumor 0 0
Testicular Yolk Sac Tumor 0 0
Testicular Choriocarcinoma 0 0
Testicular Diseases 0 0
Germ Cell Cancer Metastatic 0 0
Germ Cell Neoplasm of Retroperitoneum 0 0
Germ Cell Cancer, Nos 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Testicular
Cancer 0 0 0 0
Other cancer types
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Axumin PET scan

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


Treatment: Drugs: Axumin PET scan
PET scan prior to RPLND
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Performance characteristics of Axumin PET scan in patients undergoing retroperitoneal lymph node dissection
Timepoint [1] 0 0
Two years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/07/2026
Actual
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Other
Name
University of Texas Southwestern Medical Center
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Yair Lotan, MD
Address 0 0
University of Texas Southwestern Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03426865