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:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-24 @ 3:23 PM
NCT ID:
NCT06586892
Eligibility Criteria:
Inclusion Criteria:
Provide signed and dated informed consent form.
* Aged 18 years or older.
* Have histologic evidence of malignant neoplasm that may have been obtained from the primary tumor or metastatic lymph node.
* Have a clinical decision made to receive external beam radiation therapy (EBRT) with curative intent, with or without concomitant chemotherapy.
* Have a good performance status (ECOG score 0-2) evaluated during screening (4 weeks prior to baseline imaging).
* Be willing to comply with all study procedures.
* Be willing to participate for the duration of the study.
* Have elevated dosimetric risk mainly characterized by any of the following criteria:
* D30\>50Gy: 30% of the whole-mandible volume received a dose greater than 50 Gy
* V44 ≥ 42%: at least 42% of the volume received a dose of 44 Gy or more or
* V58 ≥ 25%: at least 25% of the volume received a dose of 58 Gy or more.
Exclusion Criteria:
Unable to tolerate DW-MRI or DCE-MRI;
* Having an estimated GFR \< 30 ml/min/1.73 m2;
* Contraindication to MRI (e.g., non-MRI compatible metallic implants)
* Pregnant females
* Unable or unwilling to give written, informed consent to undergo MRI imaging.
* Claustrophobia
* Unable to obtain imaging studies of adequate quality to assess imaging-based biomarkers.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06586892
Study Brief:
Protocol Section:
NCT06586892