Metastatic Malignant Neoplasm in the BonePhase 1NCT06549478
Biology-Guided Radiation Therapy for the Treatment of Patients With Bone Metastases
A Phase 1 study testing Computed Tomography, Image Guided Radiation Therapy and Positron Emission Tomography in people with Metastatic Malignant Neoplasm in the Bone and Metastatic Malignant Solid Neoplasm, run by City of Hope Medical Center at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Solid Neoplasm
- What is being tested?
- Computed Tomography, Image Guided Radiation Therapy and Positron Emission Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2024to 26 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented informed consent of the participant and/or legally authorized representative
- Assent, when appropriate, will be obtained per institutional guidelines
- Age: ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Pathologic diagnosis of cancer
- 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)
Show all 14Show fewer
- Concurrent treatment of up to 3 radiation fields is allowed
- Standardized uptake value maximum (SUVmax) of the target bone lesions on diagnostic PET > 6
- Size of the target bone lesion 1.5-5 cm
- Pre-screening assessment confirms that the intervention can be administered without exceeding dose constraint guidelines
- 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
- Life expectancy ≥ 6 months in the opinion of the treating investigators
- Off systemic therapy for at least one week prior and one week after study intervention
- Patients able to complete pain assessment and quality of life surveys who do not have cognitive impairment
Who cannot join
- Patients with prior radiation therapy to the treatment sites
- Untreated spinal cord compression
- Pathologic fracture at the evaluated site
- Serious medical comorbidities precluding radiotherapy
- Unable to undergo a PET/CT scan
- Pregnant and/or breastfeeding women are excluded from this study as these agents may have the potential for teratogenic or abortifacient effects
- 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
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Yi-Jen Chen, 626-218-4589, yichen@coh.org
Yi-Jen Chen
About this study
Official title: A Pilot Study of BgRT for Bone Metastases
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate pain response by 14 gray (Gy) single fraction (SF)-BgRT for patients with painful bone metastases.
SECONDARY OBJECTIVE:
- To evaluate patient-reported health related quality of life (QOL), clinician-rated toxicity per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0, radiographic evidence of disease progression at treated sites, and rate of re-irradiation.
OUTLINE:
Patients undergo a single fraction of BgRT on day 0. Patients undergo positron emission tomography (PET)/computed tomography (CT) on study and optionally during follow up.
After completion of study treatment, patients are followed up at 2 weeks, 3 months and then every 3 months for up to 1 year.
- Being tested
- Computed Tomography, Image Guided Radiation Therapy, Positron Emission Tomography, Questionnaire Administration
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo PET/CT
Image Guided Radiation TherapyRadiation
Also called IGRT, image-guided radiation therapy, Image-Guided Radiotherapy
Undergo BgRT
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (BgRT) | Experimental | Patients undergo a single fraction of BgRT on day 0. Patients undergo PET/CT on study and optionally during follow up. Receives: Procedure: Computed Tomography; Radiation: Image Guided Radiation Therapy; Procedure: Positron Emission Tomography; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicity is defined as any ≥ grade 3 gastrointestinal, genitourinary, lung, or skeletomuscular toxicities that is considered at least possibly related to the study treatment and occurs within 3 months after the treatment.
Measured: Up to 1 year follow-up
Pain response
Will be assessed using international consensus endpoints assessing a combination of pain severity and analgesic consumption. Pain progression reflects either (a) an increase in a worst-pain score of 2 or more without reduced daily morphine milligram equivalent (MME), or (b) no change in worst-pain score or 1 point above baseline and an increase in daily MME of at least 25%. Indeterminate response then indicates all other responses. Overall response is defined as sum of complete response and partial response at 3 months after single fraction-biology-guided radiation therapy.
Measured: Up to 1 year follow-up
Secondary outcomes (4)
Rates of re-irradiation
Measured: At 1 year follow-up
Radiographic evidence of disease progression
Radiographic evidence of disease progression at treated sites will be assessed using imaging scans.
Measured: Up to 1 year follow-up
Patient-reported health related quality of life (QOL)
QOL will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Bone Metastases Module.
Measured: Up to 1 year follow-up
Incidence of clinician-related chronic toxic effects
Toxicity is defined as any ≥ grade 3 gastrointestinal, genitourinary, lung, or skeletomuscular toxicities that is considered at least possibly related to the study treatment and occurs within 3 months after the treatment. Clinician-related chronic toxic effects will be assessed using the Common Terminology Criteria for Adverse Events version 5.0.
Measured: Up to 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start25 Aug 2024
- Primary completion26 Jan 2027 (estimated)
- Study completion26 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant Neoplasm in the BoneStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Yi-Jen Chen, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549478
- Sponsor's protocol ID
- 23937
- Other IDs
- NCI-2024-06473, 23937, P30CA033572
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of BgRT for Bone Metastases
- ClinicalTrials.gov ID
- NCT06549478
- Acronym / sponsor ID
- 23937
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 26 Jan 2027 (estimated)
- Study completion
- 26 Jan 2027 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate pain response by 14 gray (Gy) single fraction (SF)-BgRT for patients with painful bone metastases.
SECONDARY OBJECTIVE:
- To evaluate patient-reported health related quality of life (QOL), clinician-rated toxicity per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0, radiographic evidence of disease progression at treated sites, and rate of re-irradiation.
OUTLINE:
Patients undergo a single fraction of BgRT on day 0. Patients undergo positron emission tomography (PET)/computed tomography (CT) on study and optionally during follow up.
After completion of study treatment, patients are followed up at 2 weeks, 3 months and then every 3 months for up to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (BgRT) | Experimental | Procedure: Computed Tomography, Radiation: Image Guided Radiation Therapy, Procedure: Positron Emission Tomography, Other: Questionnaire AdministrationPatients undergo a single fraction of BgRT on day 0. Patients undergo PET/CT on study and optionally during follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Documented informed consent of the participant and/or legally authorized representative
- Age: ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Pathologic diagnosis of cancer
- 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)
Key exclusion criteria (8 listed)
- Patients with prior radiation therapy to the treatment sites
- Untreated spinal cord compression
- Pathologic fracture at the evaluated site
- Serious medical comorbidities precluding radiotherapy
- Unable to undergo a PET/CT scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo PET/CT | Procedure or surgery | Treatment (BgRT) |
| Image Guided Radiation TherapyAlso: IGRT, image-guided radiation therapy, Image-Guided RadiotherapyUndergo BgRT | Radiation | Treatment (BgRT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET/CT | Procedure or surgery | Treatment (BgRT) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (BgRT) |
Primary outcome
Incidence of adverse events
Time frame: Up to 1 year follow-up
Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicity is defined as any ≥ grade 3 gastrointestinal, genitourinary, lung, or skeletomuscular toxicities that is considered at least possibly related to the study treatment and occurs within 3 months after the treatment.
Pain response
Time frame: Up to 1 year follow-up
Will be assessed using international consensus endpoints assessing a combination of pain severity and analgesic consumption. Pain progression reflects either (a) an increase in a worst-pain score of 2 or more without reduced daily morphine milligram equivalent (MME), or (b) no change in worst-pain score or 1 point above baseline and an increase in daily MME of at least 25%. Indeterminate response then indicates all other responses. Overall response is defined as sum of complete response and partial response at 3 months after single fraction-biology-guided radiation therapy.
4 secondary outcomes
Rates of re-irradiation
Time frame: At 1 year follow-up
Radiographic evidence of disease progression
Time frame: Up to 1 year follow-up
Patient-reported health related quality of life (QOL)
Time frame: Up to 1 year follow-up
Incidence of clinician-related chronic toxic effects
Time frame: Up to 1 year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Related trials for Metastatic Malignant Neoplasm in the Bone
RecruitingObservational study
Change in Fat Fraction Quantification Before and After Treatment in Bone Metastases
Neoplasm Metastasis / Bone and Bones
Not yet recruitingPhase 1/2
ALT-100 Monoclonal Antibody (mAb) in Bone-Predominant Metastatic Androgen Pathway Modulation Resistant (APMR) Prostate Cancer -- The ALTAR-100 Trial
Prostate Cancer Metastatic to Bone
Active, not recruitingPhase 2
Oleclumab and Durvalumab for the Treatment of Recurrent, Refractory, or Metastatic Sarcoma
Metastatic Angiosarcoma, Metastatic Dedifferentiated Liposarcoma
Active, not recruiting
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
Bone Metastases, HER2-positive Breast Cancer
RecruitingObservational study
clinIcal Efficacy and Safety of Incadronate in Breast Cancer With Bone Metastases
Breast Cancer, Bone Metastases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yi-Jen Chen principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Computed Tomography, Image Guided Radiation Therapy and Positron Emission Tomography in people with Metastatic Malignant Neoplasm in the Bone and Metastatic Malignant Solid Neoplasm, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Jen Chen, MD (626-218-4589, yichen@coh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 1 year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.