RECRUITING

Biology-Guided Radiation Therapy for the Treatment of Patients with Bone Metastases

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Conditions

Metastatic Malignant Neoplasm in the BoneMetastatic Malignant Solid Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This clinical trial tests the safety and effectiveness of a single-dose treatment of biology-guided radiation therapy (BgRT) in treating patients with painful cancer that has spread from where it first started (primary site) to the bone (bone metastases). Bone metastases can result in significant pain and reduction in quality of life. Single fraction radiation therapy (SFRT) can produce equivalent pain relief compared to multi-fraction radiation therapy, but SFRT treatments generally lead to higher rates of retreatment. BgRT is a new and innovative form of radiation delivery that uses a signal generated by positron emission tomography to guide external beam radiation therapy. It is a technology breakthrough that uses live, continuously updated data throughout the entire treatment session to determine exactly where to deliver radiotherapy to biologically active tumors. Giving BgRT may be safe and effective in treating patients with painful bone metastases.

Official Title

A Pilot Study of BgRT for Bone Metastases

Quick Facts

Study Start:2024-07-26
Study Completion:2027-01-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06549478

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented informed consent of the participant and/or legally authorized representative
  2. * Assent, when appropriate, will be obtained per institutional guidelines
  3. * Age: ≥ 18 years
  4. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  5. * Pathologic diagnosis of cancer
  6. * Painful bone metastases from any solid cancers (i.e., a score of at least 2 on a 0-10 scale, 0 representing no pain and 10 representing maximum pain)
  7. * Concurrent treatment of up to 3 radiation fields is allowed
  8. * Standardized uptake value maximum (SUVmax) of the target bone lesions on diagnostic PET \> 6
  9. * Size of the target bone lesion 1.5-5 cm
  10. * Pre-screening assessment confirms that the intervention can be administered without exceeding dose constraint guidelines
  11. * Patients with brain metastases can be included but brain metastases must be treated prior to enrollment and follow up magnetic resonance imaging (MRI) 3 months after treatment shows stable findings
  12. * Life expectancy ≥ 6 months in the opinion of the treating investigators
  13. * Off systemic therapy for at least one week prior and one week after study intervention
  14. * Patients able to complete pain assessment and quality of life surveys who do not have cognitive impairment
  1. * Patients with prior radiation therapy to the treatment sites
  2. * Untreated spinal cord compression
  3. * Pathologic fracture at the evaluated site
  4. * Serious medical comorbidities precluding radiotherapy
  5. * Unable to undergo a PET/CT scan
  6. * Pregnant and/or breastfeeding women are excluded from this study as these agents may have the potential for teratogenic or abortifacient effects
  7. * Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements
  8. * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics, patients who exhibit cognitive impairments/ who are unable to complete study materials: assessments/questionnaires)

Contacts and Locations

Study Contact

Yi-Jen Chen, MD
CONTACT
626-218-4589
yichen@coh.org

Principal Investigator

Yi-Jen Chen
PRINCIPAL_INVESTIGATOR
City of Hope Medical Center

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

  • Yi-Jen Chen, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-26
Study Completion Date2027-01-26

Study Record Updates

Study Start Date2024-07-26
Study Completion Date2027-01-26

Terms related to this study

Additional Relevant MeSH Terms

  • Metastatic Malignant Neoplasm in the Bone
  • Metastatic Malignant Solid Neoplasm