ArthritisPhase 1NCT07478679
Radiation to Treat Joint Damage Caused by Cancer Immunotherapy
A Phase 1 study testing Low dose radiation therapy in people with Arthritis and Arthropathy, run by University of Chicago at 1 site in United States.
Trial summary
This study will prospectively investigate the feasibility and safety of administering LDRT in patients with immunotherapy-induced inflammatory arthritis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Arthritis, Arthropathy
- What is being tested?
- Low dose radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2026to 17 Sep 2028
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which they are receiving single agent or combination immunotherapy or within the last 6 months.
- Rheumatologist-established diagnosis of new onset CTCAE grade 2-3 immunotherapy-induced inflammatory arthritis or activated osteoarthritis, involving one or more joints (up to 3) including but not limited to hands, shoulders, elbows, hips, knees and ankles.
- Age ≥ 40 years.
- ECOG performance status ≤2 (Karnofsky ≥60%).
- Patients with ability and willingness to sign consent.
Who cannot join
- Contraindications to radiation treatment, such as pregnancy, breast-feeding women and active collagen-vascular disease.
- Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was >1 year prior to consent and/or clear documentation states that the patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to initiation of study treatment.
- Have not received systemic steroids within the last 3 months for the treatment of immune related adverse events.
- History of prior autoimmune conditions, or concurrent immune related adverse events requiring systemic immunosuppressants.
- Estimated life expectancy less than 3 months as assessed by investigators.
- Any condition at the discretion of investigator that will preclude participation in the study.
- History of secondary malignancy as assessed by investigators.
- History of radiation to affected joints as assessed by investigators.
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
The University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Clinical Trials Intake, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Pankti Reid
About this study
Official title: Use of Low-Dose RADiotherapy in the Management of Immune Checkpoint- Inhibitor-ArThropathy as an Immune-Related Adverse Event (RADIATE)
This study will prospectively investigate the feasibility and safety of administering LDRT in patients with immunotherapy-induced inflammatory arthritis.
- Conditions
- Arthritis, Arthropathy
- Being tested
- Low dose radiation therapy
- Keywords
- Radiotherapy, Arthropathy, Immunotherapy, Cancet
- Medical subject headings
- Arthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose radiation therapyRadiation
0.5 Gy per treatment x 6 treatments, given 2-3 treatments per week over 2-3 weeks (Can be given concurrently with IO)
| Study group | Role | What they receive |
|---|---|---|
| Radiation treatment | Experimental | Not described Receives: Radiation: Low dose radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation therapy
To assess the safety and feasibility of administering Low dose radiation therapy (LDRT) in patients with immunotherapy-induced arthritis. Number of patients that experience at least one treatment related Common Terminology Criteria for Adverse Events (CTCAE) grade 4 or 5 side effect.
Measured: 3 months post enrollment.
Secondary outcomes (5)
Effectiveness of Radiation in treating immunotherapy-induced arthritis.
To assess pain relief in patients using the Common Terminology Criteria for Adverse Events (CTCAE) v5 pain assessment. Grade 1 represents mild pain or mild pain with inflammation, erythema, or joint swelling. Grade 2 represents moderate pain/moderate pain with signs of inflammation, erythema, or joint swelling, limiting instrumental activities of daily living (ADLs). Grade 3 represents severe pain/severe pain with signs of inflammation, erythema, or joint swelling, irreversible joint damage, limiting instrumental activities of daily living (ADLs).
Measured: 3 months post enrollment.
To examine the use of steroids.
Change in the daily use of rescue analgesics and need for steroids specifically for immunotherapy induced arthritic pain.
Measured: 3 months post enrollment.
To examine the use of rescue analgesics.
Change in the daily use of rescue analgesics and need for steroids specifically for immunotherapy induced arthritic pain.
Measured: 3 months post enrollment.
Effectiveness of Radiation in treating immunotherapy-induced arthritis.
To assess pain relief in patients using the Visual Analogue Pain Scale (VAPS) score. The scale is bordered by "no pain" (score of 0) and "worst imaginable pain" (score of 10)
Measured: 3 months post enrollment.
Effectiveness of Radiation in treating immunotherapy-induced arthritis.
To assess pain relief in patients using the Von Pannewitz Score (VPS). The responses are rated as follows: stable (no improvement), slightly improved, markedly improved, and painless.
Measured: 3 months post enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start26 Aug 2026 (estimated)
- Primary completion17 Sep 2028 (estimated)
- Study completion17 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pankti Reid, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478679
- Sponsor's protocol ID
- IRB25-1455
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Low-Dose RADiotherapy in the Management of Immune Checkpoint- Inhibitor-ArThropathy as an Immune-Related Adverse Event (RADIATE)
- ClinicalTrials.gov ID
- NCT07478679
- Acronym / sponsor ID
- IRB25-1455
- Conditions
- Arthritis, Arthropathy
- Keywords
- Radiotherapy, Arthropathy, Immunotherapy, Cancet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 26 Aug 2026 (estimated)
- Primary completion
- 17 Sep 2028 (estimated)
- Study completion
- 17 Sep 2028 (estimated)
- First posted
- 17 Mar 2026 (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 study will prospectively investigate the feasibility and safety of administering LDRT in patients with immunotherapy-induced inflammatory arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation treatment | Experimental | Radiation: Low dose radiation therapy |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which they are receiving single agent or combination immunotherapy or within the last 6 months.
- Rheumatologist-established diagnosis of new onset CTCAE grade 2-3 immunotherapy-induced inflammatory arthritis or activated osteoarthritis, involving one or more joints (up to 3) including but not limited to hands, shoulders, elbows, hips, knees and ankles.
- Age ≥ 40 years.
- ECOG performance status ≤2 (Karnofsky ≥60%).
- Patients with ability and willingness to sign consent.
Key exclusion criteria (8 listed)
- Contraindications to radiation treatment, such as pregnancy, breast-feeding women and active collagen-vascular disease.
- Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was >1 year prior to consent and/or clear documentation states that the patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to initiation of study treatment.
- Have not received systemic steroids within the last 3 months for the treatment of immune related adverse events.
- History of prior autoimmune conditions, or concurrent immune related adverse events requiring systemic immunosuppressants.
- Estimated life expectancy less than 3 months as assessed by investigators.
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 |
|---|---|---|
| Low dose radiation therapy0.5 Gy per treatment x 6 treatments, given 2-3 treatments per week over 2-3 weeks (Can be given concurrently with IO) | Radiation | Radiation treatment |
Primary outcome
Radiation therapy
Time frame: 3 months post enrollment.
To assess the safety and feasibility of administering Low dose radiation therapy (LDRT) in patients with immunotherapy-induced arthritis. Number of patients that experience at least one treatment related Common Terminology Criteria for Adverse Events (CTCAE) grade 4 or 5 side effect.
5 secondary outcomes
Effectiveness of Radiation in treating immunotherapy-induced arthritis.
Time frame: 3 months post enrollment.
To examine the use of steroids.
Time frame: 3 months post enrollment.
To examine the use of rescue analgesics.
Time frame: 3 months post enrollment.
Effectiveness of Radiation in treating immunotherapy-induced arthritis.
Time frame: 3 months post enrollment.
Effectiveness of Radiation in treating immunotherapy-induced arthritis.
Time frame: 3 months post enrollment.
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 23 Mar 2026.
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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.
Pankti Reid principal investigator
University of Chicago
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 Low dose radiation therapy in people with Arthritis and Arthropathy, run by University of Chicago 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 5 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: opening soon, as of the sponsor's last update on 23 Mar 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 Clinical Trials Intake (855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation therapy (time frame: 3 months post enrollment.). 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 23 Mar 2026.