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New treatment option for Lung Cancer
Official title Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury
ClinicalTrials.gov ID: NCT04485286
What this study is testing
What is [68Ga]CBP8?
[68Ga]CBP8 is an investigational medicine, being studied as a potential treatment for lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to investigate the efficacy of [68Ga]CBP8 to detect collagen deposition in radiation induced tissue injury.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- for lung cancer people:
- Eligible patients will be those harboring locally advanced clinical stage I-III NSCLC who are not eligible for surgical resection, or those with...
- Age greater than 18 years
- Have the ability to give written informed consent.
- No tobacco use within the prior 6 months. for pancreatic cancer people:
You likely can't join if
- for lung cancer people:
- 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...
- Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test is required for females having child-bearing potential before the subject...
- Claustrophobic reactions;
- Research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
See the full eligibility criteria
- for lung cancer people:
- 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...
- Age greater than 18 years
- Have the ability to give written informed consent.
- No tobacco use within the prior 6 months. for pancreatic cancer people:
- 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 how well it works assessment of the investigational imaging and standard...
- Scheduled study visit 1 within 1 month prior to starting neoadjuvant chemoradiotherapy (CRT)
- people 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.
- people 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.
- for lung cancer people:
- 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...
- 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 people:
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.