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New treatment option for Metastatic Malignant Neoplasm in the Bone
Official title Biology-Guided Radiation Therapy for the Treatment of Patients With Bone Metastases
ClinicalTrials.gov ID: NCT06549478
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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)
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.