MedTrace Logo

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

NCT06634706 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-08-13

No results posted yet for this study

Summary

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

  • Thoracic Cancer
  • Head and Neck Cancer
  • Pelvic Cancer
  • Hepatobiliary Carcinoma in Situ
  • Retroperitoneal Cancer
  • Distributed and Orphan Tumors

Interventions

DEVICE

RefleXion X1 Radiotherapy System [Imaging Only]

kVCT and FDG-PET imaging using the RefleXion X1 Radiotherapy System in different anatomical regions

Sponsors & Collaborators

  • RefleXion Medical

    lead INDUSTRY

Principal Investigators

  • Sean S. Shirvani, MD · RefleXion Medical Inc

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-01-01
Completion
2027-01-01

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06634706 on ClinicalTrials.gov