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[68Ga]CBP8 Imaging for Radiation-Induced Tissue Injury
Phase 2
Recruiting
Led By Michael Lanuti, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects required to undergo pre-surgical CT of abdomen within 1 month after completion of standard neoadjuvant CRT as part of routine clinical work-up
Scheduled surgical pancreas resection within 1 month after post-CRT study visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-6 months
Awards & highlights
Study Summary
This trial will test if a new imaging agent can detect collagen damage caused by radiation therapy.
Who is the study for?
This trial is for adults with a life expectancy over 3 months who have certain types of cancer (like lung or pancreatic) and are not using tobacco. They must be able to consent, fit within MRI weight limits, and not have metal implants or severe claustrophobia. Pregnant women can't participate.Check my eligibility
What is being tested?
[68Ga]CBP8 is being tested to see if it's effective in detecting collagen in tissues damaged by radiation. Participants will undergo PET-MRI scans with this probe to assess its efficacy.See study design
What are the potential side effects?
Potential side effects may include reactions related to the PET-MRI contrast agent used during scanning, such as allergic reactions or discomfort from lying still during the scan.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I will have a CT scan of my abdomen within 1 month after finishing my initial cancer treatment.
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I am scheduled for pancreas surgery within a month after my next study visit.
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My diagnosis of pancreatic cancer is confirmed by lab tests on tissue or fluid samples.
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I am older than 18 years.
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I am 18 years or older with pancreatic cancer.
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My lung cancer is at an advanced stage but cannot be removed by surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ability of [68Ga]CBP8 to detect collagen deposition in areas of radiation injury.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Lung Cancer or Pancreatic Cancer Subjects Undergoing Radiation TherapyExperimental Treatment1 Intervention
Lung cancer or pancreatic cancer patients will receive [68Ga]CBP8 and undergo PET imaging 1) prior to radiation therapy and 2) 3-6 months after radiation therapy
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Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,782 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,409 Total Patients Enrolled
Michael Lanuti, MDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot lie comfortably on my back for scans due to my pancreatic cancer.I have been exposed to more than the recommended amount of radiation for pancreatic cancer research.I am receiving chemotherapy and radiotherapy as initial treatment based on my hospital's standards.I am claustrophobic and have pancreatic cancer.I have an appointment before starting my pre-surgery cancer treatment.My lung cancer is at an advanced stage but cannot be removed by surgery.My kidney function is low, with an eGFR under 30.You have an electrical implant like a pacemaker or pancreatic perfusion pump.You have a mental illness or social situation that would make it hard for you to follow the study rules for people with pancreatic cancer.I have another cancer that won't affect this trial's treatment.I will have a CT scan of my abdomen within 1 month after finishing my initial cancer treatment.I have a lung condition that is not cancer or caused by smoking.Your tumor has been confirmed by a standard abdominal CT scan done within the month before the study begins.I haven't had pneumonia or a serious lung infection in the last 6 weeks.I am scheduled for pancreas surgery within a month after my next study visit.My diagnosis of pancreatic cancer is confirmed by lab tests on tissue or fluid samples.I have had radiation therapy to my upper abdomen for pancreatic cancer.I weigh less than or equal to 300 lbs.I am claustrophobic.My BMI is 33 or less.You have not used any tobacco products in the last 6 months.You have an electrical implant like a pacemaker or a pump for lung cancer.You are expected to live for at least 3 more months.I cannot lie comfortably in an MR-PET scanner.I was diagnosed with acute pancreatitis within the last 6 weeks.I am not pregnant or breastfeeding, confirmed by a negative pregnancy test.I have been exposed to more than 50 mSv of radiation for my lung cancer in the last year.I do not have metal implants or metallic tattoos that could interfere with medical scans.I am older than 18 years.I am 18 years or older with pancreatic cancer.I've had an allergic reaction to MRI dye before.I do not have metal implants or metallic tattoos that could interfere with medical scans.
Research Study Groups:
This trial has the following groups:- Group 1: Lung Cancer or Pancreatic Cancer Subjects Undergoing Radiation Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment open to individuals aged 45 or older?
"This clinical trail is accepting participants who are at least 18 years of age, but must not have surpassed their 80th birthday."
Answered by AI
Is there availability for participants in this experimental protocol?
"Clinicaltrials.gov states that this clinical trial is currently enrolling patients, having been originally posted on July 19th 2020 and last edited on January 18th 2022."
Answered by AI
What is the current cohort size for this trial?
"Affirmative. The clinical trial's details hosted on clinicaltrials.gov reveal that this medical study, initially posted back in July of 2020, is actively recruiting participants. A total of 72 volunteers are needed at a single location."
Answered by AI
Has [68Ga]CBP8 received authorization from the FDA?
"Taking into consideration that this is a Phase 2 trial, with no clinical data supporting effectiveness yet but some safety evidence, [68Ga]CBP8 received an assessment of 2."
Answered by AI
Who meets the qualifications for joining this medical research venture?
"To be enrolled, individuals must have radiation fibrosis and fall in the range of 18 to 80 years old. This clinical trial is planning on recruiting a total of 72 patients."
Answered by AI
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