Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Distributed and Orphan Tumors | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Hepatobiliary Carcinoma in Situ | — | UNRESOLVED | — |
| Pelvic Cancer | Malignant Pelvic Neoplasm | ALIAS | 0.90 |
| Retroperitoneal Cancer | Malignant Retroperitoneal Neoplasm | CURATED_BROADER | 0.80 |
| Thoracic Cancer | Malignant Thoracic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RefleXion X1 Radiotherapy System [Imaging Only] | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- OTHER
- label
- Cohort 1 - Head and Neck Tumors
- description
- Tumors in the following regions: Larynx, Salivary glands, Thyroid gland, Head and Neck lymph nodes, Oral cavity, Oropharynx, Nasopharynx, and Hypopharynx
- interventionNames
- Device: RefleXion X1 Radiotherapy System [Imaging Only]
- type
- OTHER
- label
- Cohort 2 - Thoracic Tumors
- description
- Tumors in the following regions: Thoracic lymph nodes, Thymus, Esophagus, and Breast,
- interventionNames
- Device: RefleXion X1 Radiotherapy System [Imaging Only]
- type
- OTHER
- label
- Cohort 3 - Hepatobiliary Tumors
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
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