Recruiting

Observational Study

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT04281381

Conditions

Desmoid Fibromatosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cross-sectional imaging

Study Details

Brief summary:

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

Conditions

Desmoid Fibromatosis

Study ID

NCT04281381

Start date

Feb 19, 2020

Status verified date

May, 2026

Completion date

Feb 19, 2027

Anticipated

Primary completion date

Feb 19, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Desmoid Fibromatosis

Participants will have a clinical diagnosis of desmoid fibromatosis, either new or newly recurrent

Interventions

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.

Primary outcome measure

  • Progression free survival [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Aimee M Crago, MD, PhD

212-639-4807cragoa@mskcc.org

Meera Hameed, MBBS

212-639-7959hameedm@mskcc.org

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Aimee M Crago, MD, PhD

212-639-4807

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • Desmoid-Type Fibromatosis
  • Desmoid Fibromatosis
  • Desmoid
  • Fibromatosis
  • 20-026
  • Memorial Sloan Kettering Cancer Center

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-05-15.