NCT04485286 Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury
| NCT ID | NCT04485286 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2020-07-19 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 72 participants in total. It began in 2020-07-19 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to investigate the efficacy of \[68Ga\]CBP8 to detect collagen deposition in radiation induced tissue injury.
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)
Contact & Investigator
Michael Lanuti, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT04485286 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04485286 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04485286 currently recruiting?
Yes, NCT04485286 is actively recruiting participants. Contact the research team at mlanuti@mgh.harvard.edu for enrollment information.
Where is the NCT04485286 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04485286 clinical trial?
NCT04485286 is sponsored by Massachusetts General Hospital. The principal investigator is Michael Lanuti, MD at Massachusetts General Hospital. The trial plans to enroll 72 participants.
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