Clinical trial NCT03426865: Role of Axumin PET Scan in Germ Cell Tumor
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: 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
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population will be selected from patients seen in the clinic at University of Texas Southwestern Medical Center

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Performance characteristics of Axumin PET scan in patients undergoing retroperitoneal lymph node dissection
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Yair Lotan, MD
role: PRINCIPAL_INVESTIGATOR
References: