Status:
RECRUITING
Observing People With Desmoid-Type Fibromatosis
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Desmoid Fibromatosis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to closely observe people with desmoid-type fibromatosis over 1 months.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 19 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 19 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04281381
Start Date
February 19 2020
End Date
February 19 2026
Last Update
May 16 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065