Observing patients with desmoid-type fibromatosis
Official title: A Prospective Analysis of Active Observation in Patients With Desmoid-Type Fibromatosis
Run by Memorial Sloan Kettering Cancer Center · NCT04281381 · Data updated 2026-11-12
This study is tracking people with desmoid-type fibromatosis for a month to see how their condition changes using imaging tests and samples.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | February 19, 2020 |
| Main results expected | February 19, 2027 |
| Study ends | February 19, 2027 |
| Registry record updated | May 15, 2026 |
| Trial ID | NCT04281381 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a clinical diagnosis of desmoid fibromatosis that is detectable on imaging.
✕Probably not a fit
Patients with symptomatic desmoid fibromatosis requiring narcotic pain control may not benefit from this observational approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to closely monitor individuals diagnosed with desmoid-type fibromatosis for a duration of one month. Participants will undergo cross-sectional imaging, such as MRI or CT scans, to assess their condition. The study includes both newly diagnosed and recurrent cases, allowing for the collection of baseline scans and biospecimens. The goal is to gather detailed information about the disease's progression and characteristics.
Why it matters
Potential benefit: If successful, this study could enhance understanding of desmoid-type fibromatosis and improve management strategies for patients.
How similar studies have gone: While observational studies in similar conditions have shown promise, this specific approach to desmoid-type fibromatosis is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of desmoid fibromatosis, either new or newly recurrent. Both patients with sporadic and FAP-associated disease will be eligible for inclusion. Patients with clinical diagnosis of desmoid (as assessed by MSK physician) but without pathologic diagnosis may be enrolled on the study to facilitate acquisition of appropriately protocoled baseline scans and allow for biospecimen collection; these patients will be replaced for purposes of analysis if pathology does not confirm clinical diagnosis. * At least 18 years of age. * Able to undergo cross-sectional imaging by either MRI or CT with intravenous contrast * Disease detectable on cross-sectional imaging with target lesion measuring \>/= 1 cm * Eligible for management by active observation as assessed by primary MSK care provider * Willing and able to sign an informed consent document Exclusion Criteria: * Symptomatic desmoid fibromatosis requiring narcotic pain control, resulting in intestinal fistulization, or requiring inpatient admission during the 3 months prior to enrollment * Patients with intraabdominal desmoids greater than 7cm in diameter or localized within 1cm of the central mesenteric vessels and those with tumors in the head and neck * KPS performance status \</= 70 if performance status is limited due to tumor. Patients with low KPS performance status related to co-morbidities but without symptoms related to the tumor will be eligible for enrollment. * Age less than 18 years old * Strict contraindication for both cross-sectional MRI and CT imaging with intravenous contrast (e.g., as per standard institutional protocols regarding renal insufficiency or MRI incompatible implanted devices; patients requiring pre-medication to prevent contrast reactions will be eligible for study) * Unable to grant reliable informed consent * Ongoing systemic treatment for desmoid fibromatosis
Where it's running
-
Memorial Sloan Kettering Cancer Center
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Aimee M Crago, MD, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Aimee M Crago, MD, PhD
- Email: cragoa@mskcc.org
- Phone: 212-639-4807
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.