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Collagen-targeted PET Imaging for Early Interstitial Lung Disease

Primary Purpose

Interstitial Lung Disease

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
[68Ga]CBP8
Dotarem
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Interstitial Lung Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Group 1: First degree relatives of a family member with pulmonary fibrosis (n=8)

  • Age greater than 40 years
  • Have the ability to give written informed consent
  • First degree relative of a family member with pulmonary fibrosis
  • No known history of interstitial lung disease
  • No tobacco use within the prior 6 months.

Group 2: Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) (n=22)

  • Age greater than 40 years
  • Have the ability to give written informed consent
  • ILAs or early ILD (defined by presence of reticular markings and / or traction bronchiectasis but absence of a definite UIP pattern)
  • 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
  • Historical eGFR of less than 30 mL/min/1.73 m2
  • 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 PET-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)
  • Pneumonia or other acute respiratory illness within 6 weeks of study entry
  • Parenchymal lung disease except for ILD/ILAs or emphysema
  • Acute exacerbation of ILD within the prior 6 months
  • VATS within the prior 6 months
  • Prior radiation therapy to the thorax
  • Known allergy to gadolinium.

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD)

First degree relatives of a family member with pulmonary fibrosis

Arm Description

Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) will receive [68Ga]CBP8 and undergo PET-MRI.

First degree relatives of a family member with pulmonary fibrosis will receive [68Ga]CBP8 and undergo PET-MRI.

Outcomes

Primary Outcome Measures

Degree of uptake of [68Ga]CBP8
The degree of uptake of [68Ga]CBP8 in the lungs will be compared between groups and associations with disease severity and progression will be determined.

Secondary Outcome Measures

Rate of MRI contrast clearance, Kwashout, in the lungs
Kwashout rates will be compared between groups and associations with disease severity, progression, and degree of uptake of [68Ga]CBP8 will be determined.
Rate of MRI contrast arrival, Kwashin, in the lungs
Kwashin rates will be compared between groups and associations with disease severity, progression, and degree of uptake of [68Ga]CBP8 will be determined.
Peak enhancement of MRI contrast in the lungs
Peak enhancement will be compared between groups and associations with disease severity, progression, and degree of uptake of [68Ga]CBP8 will be determined.

Full Information

First Posted
May 31, 2022
Last Updated
March 13, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT05417776
Brief Title
Collagen-targeted PET Imaging for Early Interstitial Lung Disease
Official Title
Collagen-targeted PET Imaging for Early Interstitial Lung Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Boehringer Ingelheim

4. Oversight

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

5. Study Description

Brief Summary
The goal of this study is to investigate the ability of [68Ga]CBP8 to detect collagen deposition in early interstitial lung disease.
Detailed Description
[68Ga]CBP8, is a PET imaging probe which selectively binds collagen type I. Collagen deposition is a pivotal event in the development of pulmonary fibrosis. [68Ga]CBP8 binds collagen with high affinity and has excellent pharmacological and pharmacokinetic profiles. [68Ga]CBP8 was shown in a mouse model to be effective for detecting lung fibrosis and response to treatment. In addition, [68Ga]CBP8 can detect increased collagen in the lungs of patients with idiopathic pulmonary fibrosis. The goals of this study are: To determine whether collagen deposition as assessed by [68Ga]CBP8-PET MRI can detect increased collagen deposition in early interstitial lung disease and if the degree of [68Ga]CBP8 uptake predicts subsequent disease progression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD)
Arm Type
Experimental
Arm Description
Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) will receive [68Ga]CBP8 and undergo PET-MRI.
Arm Title
First degree relatives of a family member with pulmonary fibrosis
Arm Type
Experimental
Arm Description
First degree relatives of a family member with pulmonary fibrosis will receive [68Ga]CBP8 and undergo PET-MRI.
Intervention Type
Drug
Intervention Name(s)
[68Ga]CBP8
Intervention Description
An injection of up to 350 MBq of [68Ga]CBP8 will be administered intravenously followed by PET-MRI.
Intervention Type
Drug
Intervention Name(s)
Dotarem
Other Intervention Name(s)
gadoterate meglumine
Intervention Description
Dotarem will be administered during MRI portion of study.
Primary Outcome Measure Information:
Title
Degree of uptake of [68Ga]CBP8
Description
The degree of uptake of [68Ga]CBP8 in the lungs will be compared between groups and associations with disease severity and progression will be determined.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Rate of MRI contrast clearance, Kwashout, in the lungs
Description
Kwashout rates will be compared between groups and associations with disease severity, progression, and degree of uptake of [68Ga]CBP8 will be determined.
Time Frame
24 months
Title
Rate of MRI contrast arrival, Kwashin, in the lungs
Description
Kwashin rates will be compared between groups and associations with disease severity, progression, and degree of uptake of [68Ga]CBP8 will be determined.
Time Frame
24 months
Title
Peak enhancement of MRI contrast in the lungs
Description
Peak enhancement will be compared between groups and associations with disease severity, progression, and degree of uptake of [68Ga]CBP8 will be determined.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Group 1: First degree relatives of a family member with pulmonary fibrosis (n=8) Age greater than 40 years Have the ability to give written informed consent First degree relative of a family member with pulmonary fibrosis No known history of interstitial lung disease No tobacco use within the prior 6 months. Group 2: Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) (n=22) Age greater than 40 years Have the ability to give written informed consent ILAs or early ILD (defined by presence of reticular markings and / or traction bronchiectasis but absence of a definite UIP pattern) 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 Historical eGFR of less than 30 mL/min/1.73 m2 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 PET-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) Pneumonia or other acute respiratory illness within 6 weeks of study entry Parenchymal lung disease except for ILD/ILAs or emphysema Acute exacerbation of ILD within the prior 6 months VATS within the prior 6 months Prior radiation therapy to the thorax Known allergy to gadolinium.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sydney B Montesi, MD
Phone
617-724-4030
Email
sbmontesi@partners.org
First Name & Middle Initial & Last Name or Official Title & Degree
Staci Mangini
Phone
781-333-8092
Email
SMANGINI2@mgh.harvard.edu
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Staci Mangini
First Name & Middle Initial & Last Name & Degree
Sydney Montesi, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31161770
Citation
Montesi SB, Izquierdo-Garcia D, Desogere P, Abston E, Liang LL, Digumarthy S, Seethamraju R, Lanuti M, Caravan P, Catana C. Type I Collagen-targeted Positron Emission Tomography Imaging in Idiopathic Pulmonary Fibrosis: First-in-Human Studies. Am J Respir Crit Care Med. 2019 Jul 15;200(2):258-261. doi: 10.1164/rccm.201903-0503LE. No abstract available.
Results Reference
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PubMed Identifier
28381537
Citation
Desogere P, Tapias LF, Hariri LP, Rotile NJ, Rietz TA, Probst CK, Blasi F, Day H, Mino-Kenudson M, Weinreb P, Violette SM, Fuchs BC, Tager AM, Lanuti M, Caravan P. Type I collagen-targeted PET probe for pulmonary fibrosis detection and staging in preclinical models. Sci Transl Med. 2017 Apr 5;9(384):eaaf4696. doi: 10.1126/scitranslmed.aaf4696.
Results Reference
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Collagen-targeted PET Imaging for Early Interstitial Lung Disease

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