Observing People With Desmoid-Type Fibromatosis

Desmoid Fibromatosis Clinical Trial

Official title:

A Prospective Analysis of Active Observation in Patients With Desmoid-Type Fibromatosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04281381
• Other study ID #: 20-026
• Status: Recruiting
• Start date: February 19, 2020
• Est. completion date: February 19, 2025

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Aimee M Crago, MD, PhD
• Phone: 212-639-4807
• Email: cragoa[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to closely observe people with desmoid-type fibromatosis over 1 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 19, 2025
• Est. primary completion date: February 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Desmoid Fibromatosis
• Fibroma

Intervention

Diagnostic Test:
• Cross-sectional imaging
MRI with gadolinium contrast will be the imaging modality of choice. In patients with contraindications to MRI who instead undergo baseline evaluation by CT scan, tumor evaluation will be by serial CT scans with IV contrast throughout the study period.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	The primary objective of this study is to estimate progression-free survival at 12 months, with the events defined by progression via radiographic criteria (RECIST 1.1).	12 months

External Links

•   Memorial Sloan Kettering Cancer Center