Non Small Cell Lung CancerPhase 2NCT07761910
Prospective Study on Radiation Induced Cardiotoxicity Assessed By PET-CT for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing PET/CT 18F-Flurpiridaz Rest/Stress Test, Coronary CT Angiography (CCTA) and 18F-Flurpiridaz in people with Non Small Cell Lung Cancer and Cardiotoxicity, run by Indiana University at 1 site in United States.
Trial summary
Prospective clinical study designed to evaluate damage to the heart after receiving standard of care chemotherapy and radiation therapy for locally advanced Non-Small Cell Lung Cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Cardiotoxicity, Locally Advanced Non-Small Cell Lung Cancer
- What is being tested?
- PET/CT 18F-Flurpiridaz Rest/Stress Test, Coronary CT Angiography (CCTA) and 18F-Flurpiridaz
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Oct 2027
- Phase
- Phase 2
- 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
- Age ≥ 18 at time of consent
- Ability to provide written informed consent and HIPAA authorization
- Stage III NSCLC per AJCC 8th edition guideline, confirmed by pathological diagnosis and PET/CT.
- To receive standard definitive concurrent chemoradiation therapy per NCCN guidelines.
- Tumor estimated to be within 2cm of heart contour or anticipated MHD>10Gy per treating physician.
Who cannot join
- Patients treated with stereotactic body radiotherapy (SBRT).
- Prior thoracic radiotherapy.
- Exclusion for Coronary computed tomography angiography (CCTA)
- History of a severe anaphylactic reaction to iodinated contrast.
- Renal insufficiency (defined as estimated CrCl less than 30 mL/min).
- Inability to hold breath for more than 5 seconds.
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- Patients on radioactive iodine therapy.
- Second-degree AV block, third-degree AV block, and sinus node disease (such as sick sinus syndrome or symptomatic bradycardia) without a functioning pacemaker.
- Note: Resting 12-lead EKG will be ordered at the time of enrollment to be performed prior to PET/CT stress test.
- Patients with bronchospastic diseases including asthma and chronic obstructive pulmonary disease (COPD) who have an acute exacerbation or active wheezing (a high-pitched, musical, adventitious lung sound produced by airflow through the narrowed airways) on the day of PET CT exam.
- Patients who are hypotensive (systolic blood pressure less than 90 mm Hg) on the day of the PET/CT scan.
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
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Jessica Anders, 317-278-2722, jemlynn@iu.edu
Jordan Holmes, MD
About this study
Official title: Prospective Study on Radiation Induced Cardiotoxicity Assessed By PET-CT for Locally Advanced Non-Small Cell Lung Cancer
Prospective clinical study designed to evaluate damage to the heart after receiving standard of care chemotherapy and radiation therapy for locally advanced Non-Small Cell Lung Cancer (NSCLC).
Read the detailed description
As the survival for NSCLC has gradually improved, there is increasing concern about long term radiation-induced cardiac toxicities and support in minimizing the dose to the left anterior descending artery. Myocardial perfusion (the delivery of blood to the heart muscle) evaluated by PET CT scans could be a useful tool to assess early cardiac damage by radiation, so this study will prospectively and quantitatively assess myocardial blood flow and myocardial flow reserve with 18F-Flurpiridaz PET CT prior to and after radiation therapy.
- Conditions
- Non Small Cell Lung Cancer, Cardiotoxicity, Locally Advanced Non-Small Cell Lung Cancer, Radiation Therapy
- Being tested
- PET/CT 18F-Flurpiridaz Rest/Stress Test, Coronary CT Angiography (CCTA), 18F-Flurpiridaz
- Keywords
- PET-CT, Radiation Injury, locally advanced Non-Small Cell Lung Cancer, Cardiotoxicity
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Cardiotoxicity, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT 18F-Flurpiridaz Rest/Stress TestDiagnostic test
A two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT before and 3 months after SOC radiation treatment.
Coronary CT Angiography (CCTA)Device
Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque.
18F-FlurpiridazDrug
A two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT before and 3 months after SOC radiation treatment
| Study group | Role | What they receive |
|---|---|---|
| PET/CT 18F-Flurpiridaz Rest/Stress Test | Experimental | A two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT before and 3 months after SOC radiation treatment. Receives: Diagnostic Test: PET/CT 18F-Flurpiridaz Rest/Stress Test; Device: Coronary CT Angiography (CCTA); Drug: 18F-Flurpiridaz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of MBF (myocardial blood flow)
Assessed using a two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT
Measured: Pre-radiotherapy and 3 months post-radiotherapy
Secondary outcomes (4)
Changes in myocardial blood flow to the cardiac base
Assessed using a two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT
Measured: Pre-radiotherapy and 3 months post-radiotherapy
Changes in myocardial blood flow to the left ventricle
Assessed using a two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT
Measured: Pre-radiotherapy and 3 months post-radiotherapy
Changes in myocardial blood flow to right coronary artery
Assessed using a two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT
Measured: Pre-radiotherapy and 3 months post-radiotherapy
Changes in myocardial blood flow to left circumflex artery
Assessed using a two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT
Measured: Pre-radiotherapy and 3 months post-radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordan A Holmes,, Indiana University
- Investigators
- Jordan Holmes, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761910
- Sponsor's protocol ID
- CTO-IUSCCC-0896
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Radiation Induced Cardiotoxicity Assessed By PET-CT for Locally Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07761910
- Acronym / sponsor ID
- CTO-IUSCCC-0896
- Conditions
- Non Small Cell Lung Cancer, Cardiotoxicity, Locally Advanced Non-Small Cell Lung Cancer, Radiation Therapy
- Keywords
- PET-CT, Radiation Injury, locally advanced Non-Small Cell Lung Cancer, Cardiotoxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 12 Aug 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.
Prospective clinical study designed to evaluate damage to the heart after receiving standard of care chemotherapy and radiation therapy for locally advanced Non-Small Cell Lung Cancer (NSCLC).
Detailed description
As the survival for NSCLC has gradually improved, there is increasing concern about long term radiation-induced cardiac toxicities and support in minimizing the dose to the left anterior descending artery. Myocardial perfusion (the delivery of blood to the heart muscle) evaluated by PET CT scans could be a useful tool to assess early cardiac damage by radiation, so this study will prospectively and quantitatively assess myocardial blood flow and myocardial flow reserve with 18F-Flurpiridaz PET CT prior to and after radiation therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT 18F-Flurpiridaz Rest/Stress Test | Experimental | Diagnostic Test: PET/CT 18F-Flurpiridaz Rest/Stress Test, Device: Coronary CT Angiography (CCTA), Drug: 18F-FlurpiridazA two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT before and 3 months after SOC radiation treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 at time of consent
- Ability to provide written informed consent and HIPAA authorization
- Stage III NSCLC per AJCC 8th edition guideline, confirmed by pathological diagnosis and PET/CT.
- To receive standard definitive concurrent chemoradiation therapy per NCCN guidelines.
- Tumor estimated to be within 2cm of heart contour or anticipated MHD>10Gy per treating physician.
Key exclusion criteria (11 listed)
- Patients treated with stereotactic body radiotherapy (SBRT).
- Prior thoracic radiotherapy.
- Exclusion for Coronary computed tomography angiography (CCTA)
- History of a severe anaphylactic reaction to iodinated contrast.
- Renal insufficiency (defined as estimated CrCl less than 30 mL/min).
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 |
|---|---|---|
| PET/CT 18F-Flurpiridaz Rest/Stress TestA two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT before and 3 months after SOC radiation treatment. | Diagnostic test | PET/CT 18F-Flurpiridaz Rest/Stress Test |
| Coronary CT Angiography (CCTA)Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque. | Device | PET/CT 18F-Flurpiridaz Rest/Stress Test |
| 18F-FlurpiridazA two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT before and 3 months after SOC radiation treatment | Drug | PET/CT 18F-Flurpiridaz Rest/Stress Test |
Primary outcome
Change of MBF (myocardial blood flow)
Time frame: Pre-radiotherapy and 3 months post-radiotherapy
Assessed using a two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT
4 secondary outcomes
Changes in myocardial blood flow to the cardiac base
Time frame: Pre-radiotherapy and 3 months post-radiotherapy
Changes in myocardial blood flow to the left ventricle
Time frame: Pre-radiotherapy and 3 months post-radiotherapy
Changes in myocardial blood flow to right coronary artery
Time frame: Pre-radiotherapy and 3 months post-radiotherapy
Changes in myocardial blood flow to left circumflex artery
Time frame: Pre-radiotherapy and 3 months post-radiotherapy
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 15 Sep 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.
Jordan Holmes, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PET/CT 18F-Flurpiridaz Rest/Stress Test, Coronary CT Angiography (CCTA) and 18F-Flurpiridaz in people with Non Small Cell Lung Cancer and Cardiotoxicity, run by Indiana University 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 11 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 15 Sep 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jessica Anders (1 317-278-2722, jemlynn@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of MBF (myocardial blood flow) (time frame: Pre-radiotherapy and 3 months post-radiotherapy). 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 15 Sep 2026.