Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMassachusetts General Hospital
About this trial
The goal of this study is to investigate the efficacy of \[68Ga\]CBP8 to detect collagen deposition in radiation induced tissue injury.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
[68Ga]CBP8
DrugUp to 15 mCi of \[68Ga\]CBP8 will be administered to each subject. Each subject will undergo baseline imaging prior to radiation and again 3-6 months after radiation therapy.
Treatment groups
72 Participants
are divided into 1 treatment groupGroup A: Lung Cancer or Pancreatic Cancer Subjects Undergoing Radiation TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Ability of [68Ga]CBP8 to detect collagen deposition in areas of radiation injury.
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.
Time frame
3-6 MonthsSponsors and contacts
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Massachusetts General Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov