NCT06634706Not yet recruiting
SCINTIX [BgRT} Using RMRS in Solid and Soft Tissue Tumors
Performance and Safety of Biology-Guided Radiotherapy Using the RefleXion Medical Radiotherapy System in in a Variety of Solid and Soft Tissue Tumors (BIOGUIDE-X2)
Source: ClinicalTrials.gov · Last updated 13 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study proposes 6 anatomic groupings which each can be defined similarly as the "head and neck" grouping above. These 6 groupings are: (1) Head and Neck, (2) Thoracic not including lung parenchymal, (3) Hepatobiliary and other non-hepatobiliary abdominal tumors, (4) Retroperitoneal, (5) Pelvic, and (6) Distributed or orphan. The study is designed to gather essential imaging data on the RefleXion Medical Radiotherapy System (RMRS) to validate the accuracy of FDG-directed BgRT, also known as SCINTIX therapy, in various anatomical groupings. Study subjects will go through the entire SCINTIX treatment workflow, including radiopharmaceutical administration and live PET imaging, but without turning on the treatment beam. Collected data will be used offline to generate the set of machine instructions that would have been used during treatment delivery to calculate the "emulated" BgRT dose distribution, i.e., what the delivered dose would have been had the treatment beam been turned on during the session. The 6th category ("Distributed or orphan") is meant to capture tumor types that can manifest across anatomies and/or for which utilization of stereotactic radiotherapy for treatment is relatively rare, with lymphomas being a prototypical example.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 26 Sept 2024
- Start date
- 1 Dec 2025
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- RefleXion Medical
- Diseases
- Head and neck cancer
- NCT number
- NCT06634706
What you commit to
- Study type: Interventional
- Planned participants: 96
- From 1 Dec 2025 to the primary completion date, 1 Jan 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- At the physician's discretion regarding expected target motion, FDG-avid structures not intended for radiation are within:
- 3 cm from target on diagnostic PET/CT in directions where limited target motion is expected
- 4 cm from target on diagnostic PET/CT in directions where sizable target motion is expected
- 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).
Other illness
- Known allergy to FDG.
- Known psychiatric or substance abuse disorder that would interfere with conduct of the study.
- 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.
Lab values
- Clinically significant blood glucose abnormalities that preclude a satisfactory FDG PET/CT scan.
Other
- Lung parenchymal and bone target tumors
- Pregnant, breast-feeding or expecting to conceive during the study.
- Patient weight exceeding the weight limit outlined per user manual.
Who the study is looking for
- Age greater than 21 years.
- A new or prior diagnosis of biopsy-proven cancer.
- 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).
- Target tumor size ≥2cm and ≤5cm.
- Target tumor is discrete and assessed by investigator to meet diagnostic PET screening criteria for BgRT candidacy:
- SUVmax≥6, as assessed on diagnostic PET/CT performed within 60 days of enrollment with no new intervening oncologic therapies.
- 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.
- ECOG Performance Status 0-3.
- 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.
- Females of childbearing potential should have a negative urine or serum pregnancy test within 14 days prior to initiation of study scans.
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.