Actively Recruiting

Phase 1
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT03535545

Preliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer, and Idiopathic Pulmonary Fibrosis Patients

Led by Massachusetts General Hospital · Updated on 2026-02-27

100

Participants Needed

1

Research Sites

465 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this study is to investigate the safety of \[68Ga\]CBP8 and its efficacy to detect collagen deposition in pulmonary fibrosis.

CONDITIONS

Official Title

Preliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer, and Idiopathic Pulmonary Fibrosis Patients

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Enrollment will not exceed 100 subjects across all groups
  • For healthy subjects: age over 18 years, healthy based on physical exam and medical history, no pulmonary disease (except nodules), no prior tobacco use
  • For lung cancer patients: age over 18 years, locally advanced stage IIIA NSCLC, candidates for chemotherapy, radiation, and surgery, no tobacco use within 6 months
  • For pulmonary fibrosis patients: age 40 to 80 years, diagnosis of IPF with UIP or probable UIP pattern or other fibrotic interstitial lung diseases, no tobacco use within 6 months
  • For chronic lung allograft dysfunction patients: age 40 to 80 years, post lung transplant with clinical diagnosis of CLAD, no tobacco use within 6 months
  • For immune-checkpoint-inhibitor pneumonitis patients: age over 18 years, CT findings with ground glass opacities or fibrotic changes related to recent ICI therapy, no tobacco use within 6 months
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Presence of electrical implants like pacemakers or perfusion pumps
  • Ferromagnetic implants including aneurysm clips, surgical clips, prostheses, artificial hearts, steel valves, metal fragments, shrapnel, or metallic tattoos
  • Estimated glomerular filtration rate below 30 mL/min/1.73 m2 within past 90 days for CLAD patients
  • History of chronic kidney disease for healthy, lung cancer, pulmonary fibrosis, and ICI pneumonitis groups
  • Pregnant or breastfeeding females (negative pregnancy test required prior to participation)
  • Claustrophobia
  • Cumulative research-related radiation exposure exceeding 50 mSv in the past 12 months
  • Inability to lie comfortably inside the MR-PET scanner
  • Body mass index over 33
  • Clinically unsuitable as determined by investigators
  • Known pulmonary disease outside of the study groups, recent pneumonia or respiratory infections within 6 weeks (except for pulmonary fibrosis group)
  • Prior thoracic radiation therapy except for lung cancer patients
  • Pneumonia or acute respiratory illness within 6 weeks before study entry (except pulmonary fibrosis group)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

S

Sydney B Montesi, MD

CONTACT

A

Abimbola Akinniyi

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

DIAGNOSTIC

Number of Arms

5

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