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NCT06634706

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

Not yet recruiting NA Last updated 13 August 2025
What this trial tests

NA trial testing RefleXion X1 Radiotherapy System [Imaging Only] in Thoracic Cancer in 96 participants. Not yet recruiting.

Timeline
1 December 2025
Primary endpoint
1 January 2027
1 January 2027

Quick facts

Lead sponsorRefleXion Medical
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingnone
Primary purposediagnostic
Enrollment96
Start date1 December 2025
Primary completion1 January 2027
Estimated completion1 January 2027

Drugs / interventions tested

Conditions studied

Sponsor

RefleXion Medical

Who can join

21 and older, any sex, with Thoracic Cancer or Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Expanding SCINTIX Biology-Guided Radiotherapy Beyond Lung and Bone: A Planning Feasibility and Dosimetric Study on the RefleXion X1 System.
    Zhang H, Gibbard G, Shen C, Banks TI, et al · · 2025 · cited 3× · PMID 40785471 · DOI 10.1177/15330338251365334

Verify or expand the search:

Other recruiting trials for Thoracic Cancer

Currently open trials in the same condition.

Other RefleXion Medical trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06634706.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing