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

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ClinicalTrials.gov Identifier: NCT03535545
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : August 3, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Peter David Caravan, Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Pulmonary Fibrosis Lung Cancer Drug: [68Ga]CBP8 Diagnostic Test: PET Imaging Phase 1

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Healthy control subjects will be enrolled first and then subjects with lung cancer and idiopathic pulmonary fibrosis meeting inclusion criteria.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Preliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer Patients Undergoing Radiation Therapy Prior to the Resection of Locally Advanced Tumors, and Idiopathic Pulmonary Fibrosis Patients
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2020


Arm Intervention/treatment
Experimental: Healthy Individuals
Healthy volunteers will receive [68Ga]CBP8 and undergo PET imaging.
Drug: [68Ga]CBP8
Up to 15 mCi of [68Ga]CBP8 will be administered to each subject.

Diagnostic Test: PET Imaging
All subjects will undergo PET imaging after administration of [68Ga]CBP8.

Experimental: Lung Cancer Subjects
Lung cancer patients will receive [68Ga]CBP8 and undergo PET imaging.
Drug: [68Ga]CBP8
Up to 15 mCi of [68Ga]CBP8 will be administered to each subject.

Diagnostic Test: PET Imaging
All subjects will undergo PET imaging after administration of [68Ga]CBP8.

Experimental: Idiopathic Pulmonary Fibrosis Subjects
Idiopathic Pulmonary Fibrosis patients will receive [68Ga]CBP8 and undergo PET imaging.
Drug: [68Ga]CBP8
Up to 15 mCi of [68Ga]CBP8 will be administered to each subject.

Diagnostic Test: PET Imaging
All subjects will undergo PET imaging after administration of [68Ga]CBP8.




Primary Outcome Measures :
  1. Ability to detect increased collagen deposition in pulmonary fibrosis. [ Time Frame: Two hours ]
    Probe lung uptake will be measured in IPF subjects and compared to lung uptake in healthy volunteers. We expect greater uptake in the lungs of IPF patients.


Secondary Outcome Measures :
  1. Ability of the degree of collagen deposition to predict disease progression. [ Time Frame: Up to 36 months ]
    Probe lung uptake in IPF patients will be correlated with change in forced vital capacity over the prior 12 months and prospectively over the following 12-36 months.


Other Outcome Measures:
  1. Ability of [68Ga]CBP8 to detect collagen deposition in areas of radiation injury. [ Time Frame: Up to 3 months ]
    Probe lung uptake will be measured in lung cancer patients prior to surgical resection and compared to histologic measures of fibrosis.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Group 1: Healthy subjects (n=5)
  • 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 patient subjects (n=10)

  • 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 IPF (n=10)

  • Definite IPF as defined by ATS/ERS/JRS/ALAT International Consensus Statement on IPF;
  • Age: 50-80 years old;
  • 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;
  • 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);
  • Known history of pulmonary disease (except for IPF 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 IPF), pneumonia defined with elevated WBC, fever, infiltrate on CXR and need for antibiotics

Exclusion criteria specific to Group 2:

- Stage IIIA NSCLC patients who undergo definitive bimodality therapy, i.e. chemotherapy and radiation without resection will be excluded.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535545


Contacts
Contact: Sydney B Montesi, MD 617 724 4030 sbmontesi@partners.org
Contact: Lloyd L Liang 617 724 5548 llliang@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Sydney Montesi, MD         
Principal Investigator: Sydney Montesi, MD         
Sponsors and Collaborators
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Sydney B Montesi, MD Massachusetts General Hospital

Publications:
Responsible Party: Peter David Caravan, Associate Professor of Radiology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03535545     History of Changes
Other Study ID Numbers: 2017P002718
R01HL131907 ( U.S. NIH Grant/Contract )
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peter David Caravan, Massachusetts General Hospital:
PET Imaging
Molecular Imaging

Additional relevant MeSH terms:
Lung Neoplasms
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Lung Diseases, Interstitial