Actively Recruiting
A Prospective Analysis of Active Observation in Patients With Desmoid-Type Fibromatosis
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-15
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing people with desmoid-type fibromatosis, a condition involving abnormal growth of fibrous tissue, to understand its progression over a period of at least one month. The study includes individuals newly diagnosed or with newly recurrent disease, aiming to monitor the condition without immediate treatment intervention. This observational study is sponsored by Memorial Sloan Kettering Cancer Center and focuses on tracking disease changes over time. Participants will undergo cross-sectional imaging using MRI with gadolinium contrast as the preferred method. For those unable to have MRI, CT scans with intravenous contrast will be used instead. The study involves active observation, with imaging assessments carried out to measure tumor size and progression. This approach allows researchers to evaluate the natural course of desmoid fibromatosis while participants are managed without systemic treatment. During the study, participants will have baseline and follow-up imaging scans to monitor tumor size and disease progression. Researchers will assess progression-free survival at 12 months as the primary outcome. Participants must be able to undergo imaging tests and provide informed consent. The study will monitor safety and disease status throughout the observation period, which may extend beyond the initial month based on clinical follow-up and imaging results.
CONDITIONS
Brief Title
Observing People With Desmoid-Type Fibromatosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of desmoid fibromatosis, either new or newly recurrent, including sporadic and FAP-associated disease
- At least 18 years of age
- Able to undergo cross-sectional imaging by MRI or CT with intravenous contrast
- Disease detectable on imaging with at least one lesion measuring 1 cm or larger
- Eligible for management by active observation as assessed by primary care provider
- Willing and able to sign an informed consent document
You will not qualify if you...
- Symptomatic desmoid fibromatosis requiring narcotic pain control, causing intestinal fistulization, or needing inpatient admission within 3 months prior to enrollment
- Intraabdominal desmoids larger than 7 cm or located within 1 cm of central mesenteric vessels, or tumors in the head and neck
- Karnofsky performance status (KPS) 70 or less if limited due to tumor; low KPS from other conditions allowed
- Age under 18 years
- Contraindication to both MRI and CT imaging with intravenous contrast
- Unable to provide reliable informed consent
- Currently receiving systemic treatment for desmoid fibromatosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial imaging at baseline
Participants undergo cross-sectional imaging using MRI or CT scans with intravenous contrast to detect and evaluate desmoid fibromatosis lesions.
1 visit (in-person)
Duration - Up to 12 months
Participants are observed over time with periodic imaging to monitor the progression of desmoid fibromatosis without active intervention.
Periodic imaging visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
A
Aimee M Crago, MD, PhD
M
Meera Hameed, MBBS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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