Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury (NCT04485286) | Clinical Trial Compass
RecruitingPhase 2
Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury
United States72 participantsStarted 2020-07-19
Plain-language summary
The goal of this study is to investigate the efficacy of \[68Ga\]CBP8 to detect collagen deposition in radiation induced tissue injury.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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What they're measuring
1
Ability of [68Ga]CBP8 to detect collagen deposition in areas of radiation injury.