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New scan could spot lung scarring early in fibrosis and cancer patients

NCT ID NCT03535545

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study is testing a new imaging agent called [68Ga]CBP8 to see if it can safely and accurately detect collagen buildup (scarring) in the lungs. Researchers will compare scans from healthy volunteers, lung cancer patients, and people with pulmonary fibrosis. The goal is to improve diagnosis and track disease progression over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2018

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Total enrollment for all groups will not exceed 100 subjects. * Group 1: Healthy subjects * Age greater than 18 years * Be deemed healthy at screening visit as determined by the physician investigator or nurse practitioner, based on the following assessments at Screening: physical examination, medical history, and vital signs * Have the ability to give written informed consent; * No known history of pulmonary disease (excluding pulmonary nodules); * No prior history of tobacco use. 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. * Age greater than 18 years * Have the ability to give written informed consent. * No tobacco use within the prior 6 months. Group 3: Subjects with pulmonary fibrosis * IPF (with a UIP or probable UIP pattern); or other forms of interstitial lung disease (ILD), including CTD-ILD, with a fibrotic component as noted by the presence of reticular markings and / or traction bronchiectasis and / or honeycombing on CT; * Age: 40-80 years old; * Have the ability to give written informed consent; * No tobacco use within the prior 6 months Group 4: Subjects with chronic lung allograft dysfunction (CLAD) * Status post lung transplantation * Clinical diagnosis of chronic lung allograft dysfunction * Age: 40-80 years old; * Have the ability to give written informed consent; * No tobacco use within the prior 6 months Group 5: Subjects with immune-checkpoint-inhibitor (ICI) pneumonitis * CT findings with ground glass opacities / consolidation or fibrotic changes with new onset during or within 3 months of receipt of ICI therapy * Age greater than 18 years * Have the ability to give written informed consent * No tobacco use within the prior 6 months Exclusion Criteria: * 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 for group 4 subjects; history of chronic kidney disease for subjects in groups 1-3 and 5; * 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; * BMI \> 33 (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 for pulmonary fibrosis in the study group, ICI pneumonitis in the study group, or CLAD in the study group), recent pneumonia or respiratory tract infections within 6 weeks of enrollment, prior radiation therapy to the thorax (except for the lung cancer patients in aim 2); * Pneumonia or other acute respiratory illness within 6 weeks of study entry (except for pulmonary fibrosis), pneumonia defined with elevated WBC, fever, infiltrate on CXR and need for antibiotics

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

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Other studies related to the condition(s) this trial covers.