NCT04281381 · Memorial Sloan Kettering Cancer Center
Observing People With Desmoid-Type Fibromatosis
What this study is about
The purpose of this study is to closely observe people with desmoid-type fibromatosis over 1 months.
View original scientific description
The purpose of this study is to closely observe people with desmoid-type fibromatosis over 1 months.
Interventions
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.
Primary outcome measures
Progression free survival
Time frame: 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 15, 2026 · Source of record for eligibility and locations