Recruiting NCT04281381

Observing People With Desmoid-Type Fibromatosis

— Observational Desmoid Fibromatosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Cross-sectional imaging.
Who it may be relevant to: Registry conditions: Desmoid Fibromatosis. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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

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

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.

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

NCT: NCT04281381 · 20-026