← Back to Search

Radiopharmaceutical

[68Ga]CBP8 PET Imaging for Idiopathic Pulmonary Fibrosis

Phase 1
Recruiting
Led By Sydney B Montesi, 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
Group 1: Healthy subjects - Age greater than 18 years
Group 2: Lung cancer subjects - Eligible patients will be those harboring locally advanced clinical stage IIIA NSCLC who are deemed candidates for multi-modality therapy, i.e. concurrent chemotherapy and radiation followed by pulmonary resection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Study Summary

This trial will study if a new imaging agent is safe for use in patients with pulmonary fibrosis and if it can help detect collagen deposition.

Who is the study for?
This trial is for healthy adults, lung cancer patients eligible for multi-modality therapy, and those with pulmonary fibrosis aged 40-80. Participants must not have used tobacco recently and should be able to consent. Pregnant individuals, those with certain implants or a high BMI, or recent respiratory infections are excluded.Check my eligibility
What is being tested?
[68Ga]CBP8 and PET imaging are being tested to see if they can safely detect collagen in the lungs related to fibrosis. The study includes three groups: healthy individuals, lung cancer patients undergoing specific treatment, and people with pulmonary fibrosis.See study design
What are the potential side effects?
Potential side effects aren't specified but may include reactions typical of PET imaging agents such as discomfort at injection site or allergic reactions. Excessive radiation exposure is also monitored to avoid associated risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 years old and healthy.
Select...
I have stage IIIA NSCLC and am a candidate for combined treatment including surgery.
Select...
I have a type of lung scarring known as pulmonary fibrosis or another similar lung condition.
Select...
I am over 18 and have lung cancer.
Select...
I have pulmonary fibrosis and haven't used tobacco in the last 6 months.
Select...
I have lung cancer and haven't used tobacco in the last 6 months.
Select...
I am between 40 and 80 years old with pulmonary fibrosis.
Select...
I can sign and understand the consent form for the study.
Select...
I am healthy and have no history of lung diseases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ability to detect increased collagen deposition in pulmonary fibrosis.
Secondary outcome measures
Ability of the degree of collagen deposition to predict disease progression.
Other outcome measures
Ability of [68Ga]CBP8 to detect collagen deposition in areas of radiation injury.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Pulmonary Fibrosis SubjectsExperimental Treatment2 Interventions
Idiopathic pulmonary fibrosis patients or patients with other types of interstitial lung disease with a fibrotic component will receive [68Ga]CBP8 and undergo PET imaging.
Group II: Lung Cancer SubjectsExperimental Treatment2 Interventions
Lung cancer patients will receive [68Ga]CBP8 and undergo PET imaging.
Group III: Healthy IndividualsExperimental Treatment2 Interventions
Healthy volunteers will receive [68Ga]CBP8 and undergo PET imaging.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PET Imaging
2008
Completed Phase 3
~380

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,924 Previous Clinical Trials
13,193,323 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,819 Previous Clinical Trials
47,295,657 Total Patients Enrolled
Sydney B Montesi, MDPrincipal InvestigatorMassachusetts General Hospital

Media Library

[68Ga]CBP8 (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT03535545 — Phase 1
Lung Cancer Research Study Groups: Healthy Individuals, Lung Cancer Subjects, Pulmonary Fibrosis Subjects
Lung Cancer Clinical Trial 2023: [68Ga]CBP8 Highlights & Side Effects. Trial Name: NCT03535545 — Phase 1
[68Ga]CBP8 (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03535545 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the study open to participants who are of advanced age?

"This medical research is available to adults who are over the age of 18 and under 80 years old."

Answered by AI

Is there any risk of harm posed by PET scanning procedures?

"Our appraisal of PET Imaging's safety is a 1, as it is currently going through the first phase of clinical trials and has little supporting data concerning its efficacy."

Answered by AI

What is the current intake rate for participants of this experiment?

"Indeed, clinicaltrials.gov reveals that this medical trial is actively recruiting. It was initially posted on August 1st 2018 and the most recent update occurred on June 13th 2022. The research requires 100 individuals to be enrolled across one site."

Answered by AI

Is this trial actively seeking participants at the moment?

"Affirmative. Per the information hosted on clinicaltrials.gov, this medical trial is recruiting patients and was first posted on August 1st 2018. The most recent update was made June 13th 2022 and it requires 100 individuals from one location to participate."

Answered by AI

Which individuals are eligible to join this investigation?

"To qualify for this research trial, applicants must have a diagnosis of pulmonary fibrosis and be between 18-80 years old. Approximately 100 participants are being accepted."

Answered by AI
Recent research and studies
~29 spots leftby Jun 2026