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Detecting Radiation Injury with [68Ga]CBP8

This study is testing a new imaging agent called [68Ga]CBP8 to see how well it can find collagen buildup in tissues that have been damaged by radiation therapy. Collagen buildup can happen in conditions like radiation-induced lung injury or after radiation for pancreatic cancer. Researchers want to see if [68Ga]CBP8 can help doctors detect this damage. You might be able to join if you are between 18 and 80 years old and have certain types of lung cancer that are being treated with radiation, or if you are receiving radiation for pancreatic cancer. The main goal is to see if [68Ga]CBP8 can detect collagen in injured areas 3 to 6 months after radiation treatment. The study is currently unclear on its recruitment status and plans to enroll 72 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment or intervention. It plans to enroll 72 participants.
What's involved
You would receive an injection of [68Ga]CBP8 and undergo imaging before radiation and again 3-6 months after radiation therapy.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 3-6 months after radiation therapy to assess the imaging agent's effectiveness.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04485286

Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury

Recruiting
PHASE2Ages 18–80InterventionalDiagnostic
Massachusetts General Hospital
~72 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:[68Ga]CBP8

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ability of [68Ga]CBP8 to detect collagen deposition in areas of radiation injury.
Measured over 3-6 Months

Conditions

Lung Cancer
Radiation Fibrosis
Radiation Induced Lung Injury
Pancreas Cancer

Explore related trials

Lung Non-Small Cell CarcinomaPancreatic Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Michael Lanuti, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
  • Shadi Esfahani, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Michael Lanuti, MD
[email protected]
6176430193
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

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
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)

What this trial measures

  • Ability of [68Ga]CBP8 to detect collagen deposition in areas of radiation injury.3-6 Months

    Probe uptake will be measured in lung cancer or pancreatic cancer patients 1) prior to radiation therapy and 2) 3-6 months after radiation therapy. We expect \[68Ga\]CBP8 signal to be increased in post radiation measurements over pre-radiation measurements in areas of irradiated tissue. Furthermore we expect that these areas will go on to develop radiation fibrosis.