Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases

NCT07202273 | Recruiting DMC FDA Device

• 1 other identifier: HCI193478
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to provide proof that patients can be treated with simulation-free, single-fraction palliative radiation therapy with a single in-person visit.

Conditions

Bone Metastases

Outcome Measures

Primary Outcomes (1)

• To assess the rate at which the intervention is delivered with fidelity to protocol.

  To provide proof-of-concept that patients can be treated with simulation-free, single-fraction palliative radiation therapy with only a single in-person visit to Huntsman Cancer Hospital (HCH). This will be defined as receiving simulation-free, single-fraction radiation therapy with documented real-time approval by the radiation oncologist, medical physicist, and radiation therapist that the treatment adequately covers the target without unreasonable or unsafe differences.

  1 day

Secondary Outcomes (1)

• The percentage of patients who experience an improved Functional Assessment of Cancer Therapy Quality of Life Measurement in patients with bone pain score at 30 days post-treatment compared to baseline.

  30 days

Study Arms (1)

Simulation-free, single-fraction palliative radiation therapy

EXPERIMENTAL

Radiation: simulation-free, single-fraction palliative radiation therapy

Interventions

simulation-free, single-fraction palliative radiation therapy RADIATION

Radiation will be delivered in a single fraction. The recommended prescription dose is 8 Gy with external beam radiation therapy.

Simulation-free, single-fraction palliative radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant aged ≥ 18 years.
• Diagnosis of any cancer with one to two painful and treatable metastatic bone lesions.
• Bone metastases are causing pain or instability in the opinion of the treating investigator.
• Amenable to single fraction radiation therapy per the discretion of the treating physician.
• CT collected within 60 days of registration with adequate visualization of target site as determined by the treating investigator.
• ECOG Performance Status ≤ 2.
• Participants must adhere to the following sex and contraceptive/barrier requirements:
• If participant is of childbearing potential, they must have a negative pregnancy test ≤ 14 days before the planned date of radiation therapy. This may be completed on the day of radiation if results from the pregnancy test are available for review before treatment.
• For participants of non-child bearing potential: The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
• \< 50 years of age:
• Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
• Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
• ≥ 50 years of age:
• Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
• Had radiation-induced menopause with last menses \>1 year ago; or

You may not qualify if:

• Evidence of spinal cord compression caused by the bone metastases to be treated.
• Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
• Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
• Participants taking prohibited medications as described in Section 6.7.1.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Central Study Contacts

Rachel Kingford

CONTACT

8015850115; Rachel.kingsford@hci.utah.edu

Shane Lloyd, MD

CONTACT

8015850255; Shane.lloyd@hci.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: November 5, 2025

Record last verified: 2025-09

Locations

US (1)