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Collagen-targeted PET Imaging for Interstitial Lung Disease
Phase 2
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Group 2: Age greater than 40 years
Group 1: No known history of interstitial lung disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial will study if a new 68Ga-labeled peptide can help detect early stages of interstitial lung disease.
Who is the study for?
This trial is for people over 40 years old with early signs of interstitial lung disease (ILD) or those without ILD but have a relative with pulmonary fibrosis. Participants should not have used tobacco in the last 6 months, be pregnant, or have certain metal implants and allergies to gadolinium. They must also be able to lie comfortably in an MR-PET scanner.Check my eligibility
What is being tested?
The study tests [68Ga]CBP8's ability to detect collagen in lungs affected by early ILD using PET imaging. It compares this new method against Dotarem, a standard contrast agent, to see which better identifies early disease stages.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the contrast agents used ([68Ga]CBP8 or Dotarem), discomfort from lying still during scanning, and exposure to radiation during PET imaging.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 40 years old.
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I have never had interstitial lung disease.
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My lung condition shows early signs of scarring but not a specific severe pattern.
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I have a close family member with pulmonary fibrosis.
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I am over 40 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Degree of uptake of [68Ga]CBP8
Secondary outcome measures
Peak enhancement of MRI contrast in the lungs
Rate of MRI contrast arrival, Kwashin, in the lungs
Rate of MRI contrast clearance, Kwashout, in the lungs
Trial Design
2Treatment groups
Experimental Treatment
Group I: Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD)Experimental Treatment2 Interventions
Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) will receive [68Ga]CBP8 and undergo PET-MRI.
Group II: First degree relatives of a family member with pulmonary fibrosisExperimental Treatment2 Interventions
First degree relatives of a family member with pulmonary fibrosis will receive [68Ga]CBP8 and undergo PET-MRI.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gadoteric acid
FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,325 Total Patients Enrolled
Boehringer IngelheimIndustry Sponsor
2,505 Previous Clinical Trials
11,340,262 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a lung condition that is not ILD/ILAs or emphysema.I have not had pneumonia or a serious lung infection in the last 6 weeks.I have had radiation therapy to my chest area before.You have metal implants or objects in your body that can be affected by a magnetic field, such as certain types of surgical clips or metal fragments.I am not pregnant or breastfeeding, and I have a negative pregnancy test.I had a minimally invasive chest surgery within the last 6 months.I am over 40 years old.I have never had interstitial lung disease.My lung condition shows early signs of scarring but not a specific severe pattern.I have a close family member with pulmonary fibrosis.You have an allergy to gadolinium.Your body mass index (BMI) is higher than 33, which is the limit for the PET-MRI table.I experience severe discomfort in confined spaces.You have an electrical device like a pacemaker or pump in your body.My kidney function is low, with an eGFR under 30.I am over 40 years old.I cannot lie comfortably in an MR-PET machine.My lung condition has not worsened in the last 6 months.You have received a high amount of radiation in the past year, more than what is considered safe.You have not used any tobacco products in the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD)
- Group 2: First degree relatives of a family member with pulmonary fibrosis
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.
Are there any available positions for participants in this research?
"Yes, as the clinicaltrials.gov website reports, this study is still looking for participants. The trial was originally posted on September 1st, 2022 and the latest update was on August 22nd, 2022."
Answered by AI
Are there harmful effects associated with [68Ga]CBP8?
"[68Ga]CBP8 is considered to be a safe medication, as there is some data supporting safety but none supporting efficacy."
Answered by AI
How many willing participants are needed for this clinical trial?
"That is accurate. According to the listing on clinicaltrials.gov, this study was most recently updated on August 22nd, 2022 and they are currently enrolling 30 individuals at 1 site."
Answered by AI
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