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:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT06634706
Eligibility Criteria:
Inclusion Criteria:
1. Age greater than 21 years.
2. A new or prior diagnosis of biopsy-proven cancer.
3. At least one active non-osseous primary or metastatic tumor that is located in one of the assigned anatomical groupings and dispositioned to undergo 3-5 fractions of SBRT. A lesion is considered active if viable malignancy is confirmed either by biopsy or by diagnostic imaging (as interpreted by the multidisciplinary care team).
4. Target tumor size ≥2cm and ≤5cm.
5. Target tumor is discrete and assessed by investigator to meet diagnostic PET screening criteria for BgRT candidacy:
1. SUVmax≥6, as assessed on diagnostic PET/CT performed within 60 days of enrollment with no new intervening oncologic therapies.
2. Ratio of target tumor SUVmax to SUVmean of local background region (defined as a 3 mm shell 1.5 cm from the target tumor) is greater than 6, as assessed on diagnostic PET/CT performed within 60 days of enrollment with no new intervening oncologic therapies.
6. ECOG Performance Status 0-3.
7. Must have completed any other oncologic therapies at least 15 days prior to planned start of study procedures (preferably 30 days) and must have no plans to initiate systemic therapy until after study follow up is complete -OR- must be recorded by physician to have an active lesion that is unresponsive to ongoing systemic therapy.
8. Females of childbearing potential should have a negative urine or serum pregnancy test within 14 days prior to initiation of study scans.
Exclusion Criteria:
1. Clinically significant blood glucose abnormalities that preclude a satisfactory FDG PET/CT scan.
2. Lung parenchymal and bone target tumors
3. At the physician's discretion regarding expected target motion, FDG-avid structures not intended for radiation are within:
1. 3 cm from target on diagnostic PET/CT in directions where limited target motion is expected
2. 4 cm from target on diagnostic PET/CT in directions where sizable target motion is expected
4. Known allergy to FDG.
5. Known psychiatric or substance abuse disorder that would interfere with conduct of the study.
6. Pregnant, breast-feeding or expecting to conceive during the study.
7. Patient weight exceeding the weight limit outlined per user manual.
8. Patients with pacemakers and other implantable devices deemed at high risk by the treating physician for complications secondary to radiotherapy, according to institutional guidelines and published guidelines (e.g. AAPM task group-203).
9. Active inflammatory bowel disease, scleroderma, or other disorder deemed by the treating physician to put the patient at risk for excess toxicity in the setting of external beam radiation therapy (EBRT) or FDG injection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT06634706
Study Brief:
Protocol Section:
NCT06634706