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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT03535545
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • [68Ga]CBP8 — DRUG
    Up to 15 mCi of \[68Ga\]CBP8 will be administered to each subject.
  • PET Imaging — DIAGNOSTIC_TEST
    All subjects will undergo PET imaging after administration of \[68Ga\]CBP8.

Study Details

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

Key Dates

Start date
Aug 1, 2018
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Healthy Individuals
    Healthy volunteers will receive \[68Ga\]CBP8 and undergo PET imaging.
  • Experimental: Lung Cancer Subjects
    Lung cancer patients will receive \[68Ga\]CBP8 and undergo PET imaging.
  • Experimental: Pulmonary Fibrosis Subjects
    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.
  • Experimental: Subjects with chronic lung allograft dysfunction (CLAD)
    Subjects with chronic lung allograft dysfunction (CLAD) will receive \[68Ga\]CBP8 and undergo PET imaging.
  • Experimental: Subjects with immune-checkpoint-inhibitor (ICI) pneumonitis
    Subjects with immune-checkpoint-inhibitor (ICI) pneumonitis will receive \[68Ga\]CBP8 and undergo PET imaging.

Primary Outcome Measure

Ability to detect increased collagen deposition in pulmonary fibrosis. [ Time Frame: Two hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Sydney Montesi, MD
Sydney Montesi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Massachusetts General Hospital· Boston, MA

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