Observing People With Desmoid-Type Fibromatosis

Recruiting

• Conditions: Desmoid Fibromatosis
• Interventions: Diagnostic Test: Cross-sectional imaging

• Registration Number: NCT04281381
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2020-02-19
• Study First Submitted: 2020-02-20
• Study First Submitted QC: 2020-02-20
• Study First Posted: 2020-02-24
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-01
• Last Update Posted: 2024-03-04
• Primary Completion: 2025-02-19
• Study Completion: 2025-02-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Desmoid Fibromatosis	Cross-sectional imaging	Participants will have a clinical diagnosis of desmoid fibromatosis, either new or newly recurrent

Primary Outcome Measures

Name	Time	Method
Progression free survival	12 months	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).

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States