RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a PET scan tracer called [68Ga]CBP8 can find collagen buildup in tissue hurt by radiation. Collagen is a protein in body tissues. The study is for adults with certain lung or pancreatic cancers.

The goal of this study is to investigate the efficacy of \[68Ga\]CBP8 to detect collagen deposition in radiation induced tissue injury.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both groups: Must understand the study and be able to sign a consent form.
  • Lung cancer: Must be older than 18 and have used no tobacco in the past 6 months.
  • Lung cancer: Must have stage I–III non-small cell lung cancer that cannot be removed by surgery, or stage IIIa cancer suited for chemotherapy and radiation together, followed by lung surgery.
  • Pancreatic cancer: Must be at least 18 and expected to live more than 3 months. Must have pancreatic ductal adenocarcinoma (PDAC), confirmed by tissue or cell testing.
  • Pancreatic cancer: An abdominal CT scan within 1 month before the first study visit must confirm the tumor. Tissue samples from the diagnosis must be available at Massachusetts General Hospital.
  • Pancreatic cancer: Must plan to receive chemotherapy followed by radiation before surgery as standard care. The first study visit must be within 1 month before this treatment starts.
  • Pancreatic cancer: Must have an abdominal CT within 1 month after chemotherapy and radiation end, and pancreas surgery within 1 month after the post-treatment study visit.
  • Pancreatic cancer: A past or current other cancer is allowed if it will not affect checks of safety or how well the study imaging and standard treatment work.

Who can't join

  • Both groups: Cannot have electrical implants, such as a pacemaker or infusion pump, or metal that could be unsafe in an MRI. This includes certain implants, metal fragments, metallic tattoos, or tattoos near the eyes.
  • Both groups: Cannot be pregnant or breastfeeding. Those who could become pregnant need a negative blood pregnancy test before joining the lung group, or at each PET/MRI visit for the pancreatic group.
  • Both groups: Cannot have reactions to tight spaces or be unable to lie comfortably inside the scanner. Weight cannot be over 300 pounds for the lung group; body mass index (BMI) cannot be over 33 for the pancreatic group.
  • Both groups: Cannot have research radiation exposure above the department’s limit of 50 mSv in the past 12 months, or be judged medically unsuitable by the study doctor.
  • Lung cancer: Cannot have lung disease other than lung cancer or smoking-related lung disease. Cannot have had pneumonia or another sudden breathing illness within 6 weeks before joining.
  • Pancreatic cancer: Cannot have had radiation to the upper belly, a reaction to the MRI contrast drug gadoterate meglumine, or acute pancreatitis (sudden swelling of the pancreas) within 6 weeks before the study visit.
  • Pancreatic cancer: Cannot have a kidney filtering test result (eGFR) below 30 mL/min/1.73 m² within the past 90 days.
  • Pancreatic cancer: Cannot have an uncontrolled illness, or a mental health condition or social situation that would prevent following study requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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)

Study sites (1)

MA