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

  • STATUS
    Recruiting
  • days left to enroll
    63
  • participants needed
    25
  • sponsor
    Massachusetts General Hospital
Updated on 9 March 2021
cancer
lung cancer
pulmonary disease
pulmonary fibrosis
fibrosis
bronchiectasis
diagnostic procedures
idiopathic pulmonary fibrosis
interstitial lung disease
pulmonary resection
lung carcinoma

Summary

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

Description

The investigators have developed [68Ga]CBP8, a gallium-68 labeled collagen binding PET imaging probe, which selectively binds collagen type I. Collagen deposition is a pivotal event in several human conditions including pulmonary fibrosis. The investigator's studies in mice showed that [68Ga]CBP8 binds collagen with high affinity and has excellent pharmacological and pharmacokinetic profiles with high target uptake and low retention in background tissues and organs. [68Ga]CBP8 was shown in a mouse model to be effective for detecting lung fibrosis. [68Ga]CBP8 showed high specificity for pulmonary fibrosis and high target:background ratios in diseased animals. In addition, [68Ga]CBP8 could be used to monitor response to treatment. Ex vivo analysis of lung tissue from patients with IPF supported the animal findings.

The investigators thus aim to perform the first in human studies of [68Ga]CBP8:

  1. To evaluate the safety of [68Ga]CBP8 and its whole body distribution, metabolism, pharmacokinetics, and radiation burden in healthy volunteers.
  2. To establish the accuracy of [68Ga]CBP8-PET to detect radiation-induced fibrosis in lung cancer patients and correlate collagen-targeted [68Ga]CBP8-PET imaging with HRCT and histology in lung cancer patients.
  3. To determine whether collagen deposition as assessed by [68Ga]CBP8-PET molecular imaging can predict disease progression in IPF patients and patients with other types of ILD with a fibrotic component.

Details
Condition Pulmonary Disease, Lung Disease, Pulmonary Fibrosis, Pulmonary Fibrosis, Lung Neoplasm, Lung Cancer, Bronchial Neoplasm, Lung Cancer, Lung Disease, lung fibrosis, carcinoma lung, lung carcinoma
Treatment PET Imaging, [68Ga]CBP8
Clinical Study IdentifierNCT03535545
SponsorMassachusetts General Hospital
Last Modified on9 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Total enrollment for all groups (1, 2, and 3) will not
Age greater than 18 years
exceed 25 subjects
Group 1: Healthy subjects
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
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
Group 2: Lung cancer patient subjects
Have the ability to give written informed consent
No tobacco use within the prior 6 months
Group 3: Subjects with pulmonary fibrosis
Have the ability to give written informed consent
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
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
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
Body weight of > 300 lbs (weight 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)
Exclusion criteria specific to Group 2
Known history of pulmonary disease (except for pulmonary fibrosis 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)
Stage IIIA NSCLC patients who undergo definitive bimodality therapy, i.e. chemotherapy and radiation without resection will be excluded
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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