SCINTIX [BgRT} Using RMRS in Solid and Soft Tissue Tumors

Launched by REFLEXION MEDICAL · Oct 8, 2024

Keywords

ClinConnect Summary

The SCINTIX trial is studying a new type of cancer treatment called SCINTIX therapy, which uses a special radiotherapy system to target solid tumors located in different parts of the body, such as the head and neck, thorax, abdomen, pelvis, and some rare tumors. The goal of this research is to gather important imaging data to help validate how accurately this new treatment can deliver radiation to tumors. Participants will receive a specific type of imaging and treatment preparation but will not actually receive the radiation during the study. Instead, the information collected will help researchers understand how the treatment would work if it were given.

To be eligible for this trial, participants must be at least 21 years old and have a confirmed diagnosis of cancer with at least one active tumor that fits within the study's defined areas. The tumors should be between 2 cm and 5 cm in size, and participants need to have completed any other cancer treatments at least 15 days before starting this study. Those interested should also be aware that certain conditions may disqualify them, such as having tumors in the lungs or bones, or being pregnant. Overall, this trial aims to improve treatment options and understanding of how to effectively target different types of tumors.

Gender

ALL

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.