Biology-Guided Radiation Therapy for Bone Cancer

Overseen By Yi-Jen Chen, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: City of Hope Medical Center

Disqualifiers: Prior radiation, Spinal cord compression, Fracture, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of radiation therapy called biology-guided radiation therapy (BgRT) to determine its safety and effectiveness in treating painful bone cancer that has spread from other parts of the body. BgRT uses advanced imaging to precisely target and treat active tumors, potentially reducing pain and improving quality of life. The trial seeks individuals with solid cancers that have caused painful bone metastases. Participants must be able to rate their pain, have no prior radiation to the targeted area, and refrain from cancer medication for at least a week before and after the treatment. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial requires that participants stop taking systemic therapy (treatments that affect the entire body) for at least one week before and one week after the study intervention.

What prior data suggests that this biology-guided radiation therapy is safe for treating bone metastases?

Research has shown that biology-guided radiation therapy (BgRT) might be safe for treating bone cancer that has spread from other areas of the body. Some studies have shown promising results, and the FDA has approved a similar technology called SCINTIX for treating lung and bone tumors, including those that have metastasized. This approval suggests that BgRT could be safe, as it is being studied for similar purposes.

Although BgRT is a newer treatment, the FDA's approval of SCINTIX offers some reassurance about its safety. This technology uses advanced imaging to target tumors more precisely, potentially leading to fewer side effects than traditional radiation therapy. However, since this is an early-phase trial, it primarily focuses on safety, and not all potential risks are known yet. Participants in the trial will help researchers gather more information on how well BgRT is tolerated for bone metastases. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Biology-Guided Radiation Therapy (BgRT) is unique because it combines the precision of radiation therapy with real-time biological imaging, specifically using PET/CT scans. Unlike standard radiation treatments for bone cancer that rely on pre-treatment imaging, BgRT continuously adjusts the radiation dose based on the tumor's biological activity. This approach allows for more accurate targeting of cancerous cells, potentially reducing damage to healthy tissue and improving treatment outcomes. Researchers are excited about BgRT because it could lead to more personalized and effective cancer care, addressing the limitations of current radiation therapies.

What evidence suggests that biology-guided radiation therapy is effective for treating bone metastases?

Studies have shown that Biology-Guided Radiation Therapy (BgRT), which participants in this trial will receive, can effectively target tumors, including those in the bone. BgRT uses signals from positron emission tomography imaging to direct radiation precisely to cancer cells. This method shows promise for treating cancer that has spread to the bones. The FDA has approved a similar technology, SCINTIX, for treating bone and lung tumors, supporting BgRT's potential effectiveness. Early cases reported successful results in treating both lung and bone tumors. This innovative approach aims to relieve pain and improve the quality of life for patients with painful bone cancer spread. ^{1 2 3 5 6}

Who Is on the Research Team?

Yi-Jen Chen

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with painful cancer that has spread to the bone. Participants must have a life expectancy of at least 3 months, be able to lie still for treatment, and provide written informed consent. Those who are pregnant, breastfeeding, or have certain metal implants near the treatment area cannot join.

Inclusion Criteria

I can take care of myself and perform daily activities.

My cancer has been confirmed through lab tests.

My brain metastases have been treated and stable for 3 months.

Exclusion Criteria

I have untreated spinal cord compression.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a single fraction of biology-guided radiation therapy (BgRT) on day 0

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain response and quality of life assessments

Up to 1 year

Follow-up at 2 weeks, 3 months, and every 3 months thereafter

What Are the Treatments Tested in This Trial?

Interventions

• Biology-Guided Radiation Therapy

Trial Overview The study tests a single-dose biology-guided radiation therapy (BgRT) using live data from PET scans to target active tumors in bones. It aims to see if BgRT can effectively relieve pain without needing retreatment like standard therapies.

How Is the Trial Designed?

Group I: Treatment (BgRT) Experimental Treatment 4 Interventions

Patients undergo a single fraction of BgRT on day 0. Patients undergo PET/CT on study and optionally during follow up.

Biology-Guided Radiation Therapy is already approved in United States for the following indications:

Approved in United States as SCINTIX Biology-Guided Radiation Therapy for:

• Bone metastases
• Lung cancer

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Advancements in imaging and predictive assays are paving the way for patient-specific biologically guided radiation therapy (BGRT), which could significantly improve treatment outcomes by tailoring therapies to individual responses.

The implementation of BGRT in clinical settings is expected to evolve over the next decade, with even partial adoption potentially leading to substantial improvements in how radiation therapy is delivered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BGRT: biologically guided radiation therapy-the future is fast approaching! Stewart, RD., Li, XA.[2017]

In a study of 84 prostate cancer patients, 74% of metastatic lesions were found suitable for biology-guided radiotherapy (BgRT) using a 10-mm tracking zone, indicating a high potential for effective treatment targeting.

However, some lesions were adjacent to non-tumor tissues with PSMA uptake, such as the bladder and ureter, which may complicate BgRT and necessitate careful consideration during treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Biology-Guided Radiotherapy to De Novo Metastases Diagnosed During Staging of High-Risk Biopsy-Proven Prostate Cancer. Gaudreault, M., Chang, D., Hardcastle, N., et al.[2022]

Biology-guided radiotherapy (BgRT) is a novel radiation therapy that combines PET-CT imaging with real-time tumor tracking, allowing for precise treatment of multiple tumors during a single session.

A comprehensive process map was developed by a multidisciplinary team, outlining 15 major subprocesses and 248 steps necessary for implementing BgRT, emphasizing the unique workflow requirements for safe and effective treatment delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A detailed process map for clinical workflow of a new biology-guided radiotherapy (BgRT) machine. Hwang, MS., Lalonde, R., Huq, MS.[2022]

In a study of 434 patients treated with stereotactic body radiation therapy (SBRT) for bone metastases, a biologically effective dose (BED10) of 50 or higher was linked to better local control of oligometastatic lesions, while larger planning target volumes (PTV) for nonspine lesions predicted worse local control.

Factors such as prostate cancer histology, a performance status of 0 to 1, and a metastasis-free interval of 2 years or more were associated with improved progression-free survival (PFS) and overall survival (OS), highlighting the importance of patient selection in optimizing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Treatment Factors Associated With Improved Local Control and Survival in Oligometastatic Bone Disease: Results From a Large Single-Institution Experience Using Stereotactic Body Radiation Therapy. Thomas, MC., Chen, YH., Fite, E., et al.[2022]

Biology-guided radiotherapy (BgRT) is a promising new technique that allows real-time tracking of tumors during treatment, potentially enabling complete ablation of metastatic cancer.

This innovative approach combines PET-CT imaging with a linear accelerator to deliver targeted radiation more efficiently, which could improve patient outcomes and make advanced treatment more accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biology-guided radiotherapy: redefining the role of radiotherapy in metastatic cancer. Shirvani, SM., Huntzinger, CJ., Melcher, T., et al.[2021]

Stereotactic body radiotherapy (SBRT) demonstrated high local control rates of 95% according to WHO criteria and 98% according to RECIST criteria in a study of 59 patients with metastatic spine tumors, indicating its efficacy in managing these cases.

The study found that while WHO criteria are more sensitive to changes in tumor size, RECIST criteria are simpler and reproducible, making them a suitable standard for evaluating treatment response after SBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quantitative and comparative evaluation of stereotactic spine radiosurgery local control: proposing a consistent measurement methodology. Harel, R., Kaisman-Elbaz, T., Emch, T., et al.[2022]

In a Phase I study involving 15 patients with metastatic spinal disease, intensity-modulated, near-simultaneous CT image-guided stereotactic body radiotherapy (SBRT) was found to be a feasible and highly precise treatment method, with no observed neurologic toxicity.

The treatment setup was accurate within 1 mm of the planned isocenter, and the study reported a maximum estimated probability of paralysis of no greater than 18.1%, indicating a strong safety profile for this noninvasive approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I clinical evaluation of near-simultaneous computed tomographic image-guided stereotactic body radiotherapy for spinal metastases. Chang, EL., Shiu, AS., Lii, MF., et al.[2022]

Dynamic tumor tracking-stereotactic body radiotherapy (DTT-SBRT) demonstrated a high local control rate of 95.2% for lung tumors after 2 years, indicating its efficacy in managing lung cancer.

The treatment was associated with low severe toxicity, with only 2.1% of patients experiencing grade 3 radiation pneumonitis, and no grade 4 or 5 toxicities reported, highlighting its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-institutional phase II study on the safety and efficacy of dynamic tumor tracking-stereotactic body radiotherapy for lung tumors. Matsuo, Y., Hiraoka, M., Karasawa, K., et al.[2022]

Stereotactic body radiotherapy (SBRT) using a regimen of 24 Gy in 2 fractions has shown high efficacy for treating spinal metastases, with 1-year local control rates between 83-93.9% and low rates of treatment-related complications, such as plexopathy and radiculopathy under 5%.

This SBRT regimen is not only effective for initial treatment but also feasible for reirradiation of previously treated spine metastases, maintaining local control rates of 72-86%, making it a strong option for patients with challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for spine metastases: a review of 24 Gy in 2 daily fractions. Nguyen, EK., Ruschin, M., Zhang, B., et al.[2023]

Biology-guided radiation therapy uses biological and molecular imaging, like PET scans, to enhance the effectiveness of external beam radiotherapy by tailoring treatments to individual patient responses.

This approach has shown promise in various cancers, including thoracic, gastrointestinal, and hematologic malignancies, and advancements in imaging technology and radiotracers are expected to improve treatment outcomes further.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biology-Guided Radiation Therapy: An Evolving Treatment Paradigm. Ladbury, C., Eustace, N., Amini, A., et al.[2023]

Citations

1. reflexion.com reflexion.com/press-releases/reflexion-medical-announces-first-clinical-outcomes-for-scintix-therapy-in-lung-and-bone-tumors/

RefleXion Medical Announces First Clinical Outcomes for ... SCINTIX therapy is FDA‑cleared for FDG‑guided treatment of lung and bone tumors, including metastases, and is under investigation for additional ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12340358/

Expanding SCINTIX Biology-Guided Radiotherapy Beyond ... Based on promising clinical data, the Food and Drug Administration (FDA) granted marketing clearance for SCINTIX biology-guided radiotherapy for ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06549478?draw=2&rank=1

Biology-Guided Radiation Therapy for the Treatment of ... Giving BgRT may be safe and effective in treating patients with painful bone metastases. Detailed Description. PRIMARY OBJECTIVE: I. To evaluate pain response ...

4. journals.lww.com journals.lww.com/cnmo/fulltext/2025/09010/biology_guided_radiotherapy__a_new_frontier_in.1.aspx

Biology-guided Radiotherapy Results: We describe 4 of the first BgRT cases including successful treatments of lung (peripheral and central) and bone tumors, as well as unsuccessful ...

5. reflexion.com reflexion.com/scintix-therapy/

RADIOTHERAPY JUST Leveled Up SCINTIX technology is a novel therapy for patients with tumors in the lung or bone arising from primary and metastatic cancer.

6. cityofhope.org cityofhope.org/locations/los-angeles/departments-and-services/radiation-oncology/clinical-and-research/reflexion-bgrt

Los Angeles-Area Biology-Guided Radiation Therapy (BgRT) Performance and Safety of Biology-Guided Radiotherapy using the RefleXion Medical Radiotherapy System in Different Anatomic Regions (BIOGUIDE-X2) ...