Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-25 @ 3:10 AM
NCT ID:
NCT02476305
Eligibility Criteria:
Inclusion Criteria:
* Extra-abdominal desmoid tumor (confirmed by prior biopsy)
* 18 years of age or older
* Tumor deemed accessible for cryoablation procedure by the operator in the investigator center
* At least one measurable lesion (RECIST v1.1) using MRI (gadolinium injection mandatory)
* 90 % of destruction of the tumor achievable in one procedure of cryoablation with a possible second cryoablation procedure (if a complete treatment must be achieved).
* Progressive disease under standard treatment (after at least two lines of adequate medical therapy, including tamoxifen, non-steroid anti-inflamatory or chemotherapy), with presence of functional symptoms and/or pain The definition of progressing tumors also involves patients with RECIST stable disease, but with persistent functional disability or tumor-induced pain not controlled by adequate pain medication including narcotics.
* Unresectable tumor or tumor amenable only to mutilating surgery, deemed inappropriate, and discussed in multidisciplinary meeting (RCP)
* ECOG performance status 0-2
* Biological and hematological parameters:
* neutrophils 1,5.109/L
* platelet count 100.109/L
* No significant hemostatic abnormalities
* Subject affiliated to social security
* Signed informed consent
Exclusion Criteria:
* Any contra-indication for the procedure as stated by the radiologist in terms of tumor size, proximity to neural/vascular structures making the procedure at unacceptable risk
* Impaired hemostasis, that may interfere with the conduct of the cryoablation
* Concurrent participation in other experimental studies that could affect endpoints of this study
* Contraindication to any form of sedation
* Contraindication to MRI or gadolinium injection (proven allergy, subject with impaired renal function (defined by a creatinine clearance below 30 ml/min by MDRD formula))
* Psychiatric disorders and adults under guardianship
* Pregnancy or breastfeeding
* Patients under judicial protection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02476305
Study Brief:
Protocol Section:
NCT02476305