18F-FES PET/CT in Imaging Patients With Desmoid Tumors

study id #: NCT02374931

condition: Deep Fibromatosis/Desmoid Tumor, Familial Adenomatous Polyposis

status: Active, not recruiting

This pilot clinical trial studies fluorine (F)-18 16 alpha-fluoroestradiol (18F-FES) positron emission tomography (PET)/computed tomography (CT) in imaging patients with desmoid tumors. 18F-FES binds to estrogen receptors, which are present on desmoid tumors, and gives off radiation that may be detected by PET and CT scans. The PET/CT scan forms an image that may show where tumor cells with estrogen receptors can be found in the body.

intervention:
Radiation: F-18 16 Alpha-Fluoroestradiol
Procedure: Positron Emission Tomography
Procedure: Computed Tomography
Other: Laboratory Biomarker Analysis

start date: April 2015

estimated completion: December 2018

last updated: April 11, 2018

phase of development: Early Phase 1

size / enrollment: 3

study design:
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

study description:
PRIMARY OBJECTIVES:
I. Establish the avidity of desmoid tumors on 18F-FES PET/CT imaging.
II. Correlate 18F-FES PET avidity with degree of estrogen receptor (ER) expression by immunohistochemistry (IHC).
OUTLINE:
Patients undergo 18F-FES PET/CT imaging over 30 minutes. After completion of study, patients are followed up for 30 days.

primary outcomes:

• Standard uptake value (SUV) measured as percent injected dose per cc [Time Frame: Initial visit, average within 24 hours of imaging] [Designated as safety issue: No]
  Data will be summarized graphically and numerically. Continuous variables (e.g. SUV) will be summarized using the mean, standard deviation, and a 5 number percentile summary set (minimum, p25, p50, p75, and maximum). The Spearman correlation statistic will be used to estimate the magnitude of a linear association between SUV and IHC measures. Ninety-five percent confidence intervals will be calculated for all point estimates.

secondary outcomes:

• IHC staining intensity in tissue samples [Time Frame: Within 4 weeks of imaging done at initial visit, day 1] [Designated as safety issue: No]
  IHC staining intensity measured on an ordinal scale or dichotomized as positive or negative. Data will be summarized graphically and numerically. Categorical measures (e.g., IHC) will be summarized in frequency tables. The Spearman correlation statistic will be used to estimate the magnitude of a linear association between SUV and IHC measures. Ninety-five percent confidence intervals will be calculated for all point estimates.

inclusion criteria:
- Patients with biopsy-proven extra-abdominal desmoid tumors
- Not currently on estrogen medication for birth control, menopause, or other reason
- No anti-estrogen therapy for desmoid tumor within the past 6 months
- Demonstration of recent growth of tumor either by imaging or clinical assessment
- Both sporadic desmoid tumors and those associated with familial adenomatous polyposis (FAP) syndromes will be included

exclusion criteria:
- Pregnancy or nursing patients
- Patients who do not wish to participate

sponsor: Vanderbilt-Ingram Cancer Center

contacts:
Katherine Hartley
615-343-7185
kate.hartley@vanderbilt.edu
VICC Clinical Trials Information Program 800-811-8480

investigators: Katherine Hartley, MD

locations: United States