New PET scan could spot radiation injury early
NCT ID NCT04485286
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a special PET probe called [68Ga]CBP8 to see if it can detect tissue damage caused by radiation therapy in people with lung or pancreatic cancer. About 72 participants will get a PET scan before and 3-6 months after radiation. The goal is to find early signs of radiation fibrosis, which could help doctors manage side effects better.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2020
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for lung cancer subjects: * Eligible patients will be those harboring locally advanced clinical stage I-III NSCLC who are not eligible for surgical resection, or those with stage IIIa NSCLC who are deemed candidates for multi-modality therapy, i.e. concurrent chemotherapy and radiation followed by pulmonary resection. * Age greater than 18 years * Have the ability to give written informed consent. * No tobacco use within the prior 6 months. Inclusion Criteria for pancreatic cancer subjects: * Age ≥ 18 years. * Life expectancy of greater than 3 months. * Ability to understand and the willingness to sign a written informed consent document. * Histologically or cytologically confirmed diagnosis of PDAC. * Tumor should be confirmed with imaging based on the standard-of-care baseline abdominal CT performed within 1 month before study visit 1. * Core samples for initial diagnosis must be available at the Department of Pathology at Massachusetts General Hospital. * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational imaging and standard treatment regimen are eligible for this trial. * Scheduled study visit 1 within 1 month prior to starting neoadjuvant chemoradiotherapy (CRT) * Subjects undergo neoadjuvant chemotherapy followed by radiotherapy (CRT) as part of their standard clinical care and based on institutional standards. * Scheduled surgical pancreas resection within 1 month after post-CRT study visit. * Subjects are required to undergo pre-surgical CT of abdomen within 1 month after completion of standard neoadjuvant CRT as part of routine clinical work-up. Exclusion Criteria for lung cancer subjects: * Electrical implants such as cardiac pacemaker or perfusion pump * Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing; * Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test is required for females having child-bearing potential before the subject can participate); * Claustrophobic reactions; * Research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months); * Unable to lie comfortably on a bed inside the MR-PET; * Body weight of \> 300 lbs (weight limit of the MRI table); * Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures); * Known history of pulmonary disease (Except lung cancer or smoking related lung disease,) * Pneumonia or other acute respiratory illness within 6 weeks of study entry, pneumonia defined with elevated WBC, fever, infiltrate on CXR and need for antibiotics Exclusion Criteria for pancreatic cancer subjects: * History of radiotherapy to the upper abdomen in the past. * History of reaction to MRI contrast (Gadoterate meglumine) * Clinical or imaging diagnosis of acute pancreatitis within 6 weeks prior to study visit * Participants with uncontrolled intercurrent illness or if determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening and/or during study). * Participants with psychiatric illness/social situations that would limit compliance with study requirements. * Electrical implants such as cardiac pacemaker or perfusion pump; * Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing; * eGFR of less than 30 mL/min/1.73 m2 within the past 90 days; * Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test is required for females having child-bearing potential at each PET/MRI study visit; * Claustrophobic reactions; * Research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months); * Unable to lie comfortably on a bed inside the MR-PET; * BMI \> 33 (limit of the PET-MRI table)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Other studies related to the condition(s) this trial covers.
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