[68Ga]CBP8 PET Imaging for Idiopathic Pulmonary Fibrosis

Recruiting in Palo Alto (17 mi)

Overseen by Sydney Montesi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Massachusetts General Hospital

Disqualifiers: Electrical implants, Ferromagnetic implants, Pregnancy, Claustrophobia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment [68Ga]CBP8 for idiopathic pulmonary fibrosis?

Research shows that [68Ga]CBP8 is effective in detecting pulmonary fibrosis in animal models by targeting collagen, which is a key component in lung scarring. The probe demonstrated high specificity and a strong correlation with lung collagen levels, suggesting it could be a promising tool for noninvasive imaging of pulmonary fibrosis in humans. ^{1 2 3 4 5}

Is [68Ga]CBP8 safe for use in humans?

In a study with nine healthy volunteers, [68Ga]CBP8 was found to be safe with no adverse effects reported. It showed rapid clearance from the body, mainly through the kidneys, and had a safety profile similar to other gallium-based imaging probes. ^{1 2 3 5 6}

How is the treatment [68Ga]CBP8 different from other treatments for idiopathic pulmonary fibrosis?

[68Ga]CBP8 is unique because it is a PET imaging probe that targets type I collagen, allowing doctors to noninvasively detect and monitor lung fibrosis by visualizing collagen overexpression, which is a key feature of the disease. Unlike traditional treatments that aim to slow disease progression, this treatment helps in early detection and staging of fibrosis, potentially improving treatment outcomes. ^{1 2 3 4 5}

Research Team

Sydney Montesi, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for healthy adults, lung cancer patients eligible for multi-modality therapy, and those with pulmonary fibrosis aged 40-80. Participants must not have used tobacco recently and should be able to consent. Pregnant individuals, those with certain implants or a high BMI, or recent respiratory infections are excluded.

Inclusion Criteria

Total enrollment for all groups will not exceed 100 subjects

I am over 18 years old and healthy.

Group 1: Healthy subjects - Have the ability to give written informed consent

Exclusion Criteria

I do not have any metal implants, fragments, or metallic tattoos.

My kidney function is low, with an eGFR under 30.

You have a pacemaker or other electrical device implanted in your body.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Evaluation

Participants receive [68Ga]CBP8 and undergo PET imaging to evaluate safety, distribution, and collagen deposition

Up to 3 months

Multiple visits for imaging and evaluation

Follow-up

Participants are monitored for safety and effectiveness after imaging

Up to 36 months

Treatment Details

Interventions

• [68Ga]CBP8 (Radiopharmaceutical)

Trial Overview [68Ga]CBP8 and PET imaging are being tested to see if they can safely detect collagen in the lungs related to fibrosis. The study includes three groups: healthy individuals, lung cancer patients undergoing specific treatment, and people with pulmonary fibrosis.

Participant Groups

Group I: Subjects with immune-checkpoint-inhibitor (ICI) pneumonitis Experimental Treatment 2 Interventions

Subjects with immune-checkpoint-inhibitor (ICI) pneumonitis will receive \[68Ga\]CBP8 and undergo PET imaging.

Group II: Subjects with chronic lung allograft dysfunction (CLAD) Experimental Treatment 2 Interventions

Subjects with chronic lung allograft dysfunction (CLAD) will receive \[68Ga\]CBP8 and undergo PET imaging.

Group III: Pulmonary Fibrosis Subjects Experimental Treatment 2 Interventions

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.

Group IV: Lung Cancer Subjects Experimental Treatment 2 Interventions

Lung cancer patients will receive \[68Ga\]CBP8 and undergo PET imaging.

Group V: Healthy Individuals Experimental Treatment 2 Interventions

Healthy volunteers will receive \[68Ga\]CBP8 and undergo PET imaging.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

Findings from Research

The peptide-based PET probe 68Ga-CBP8 specifically targets collagen type I and shows high specificity for pulmonary fibrosis in a mouse model, indicating its potential for noninvasive imaging of this condition.

In vivo and ex vivo studies demonstrated a strong correlation between 68Ga-CBP8 uptake and lung collagen levels, suggesting it could effectively monitor treatment responses in pulmonary fibrosis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type I collagen-targeted PET probe for pulmonary fibrosis detection and staging in preclinical models. Désogère, P., Tapias, LF., Hariri, LP., et al.[2018]

The 68Ga-Collagen Binding Probe #8 (68Ga-CBP8) was safely administered to nine healthy volunteers, showing no adverse effects and demonstrating favorable biodistribution with rapid renal clearance.

This probe has potential for noninvasive imaging of tissue fibrosis, with pharmacokinetics indicating a quick initial distribution and a longer elimination phase, making it suitable for assessing fibrotic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biodistribution, Dosimetry, and Pharmacokinetics of 68Ga-CBP8: A Type I Collagen-Targeted PET Probe. Izquierdo-Garcia, D., Désogère, P., Fur, ML., et al.[2023]

The study developed a collagen-targeted PET probe, 64Cu-CBP7, which showed significantly higher uptake in the lungs of mice with bleomycin-induced pulmonary fibrosis compared to healthy controls, indicating its potential for early detection of lung fibrosis.

64Cu-CBP7 demonstrated superior metabolic stability and specificity for collagen, making it a promising candidate for noninvasive imaging of pulmonary fibrosis progression in vivo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization of a Collagen-Targeted PET Probe for Molecular Imaging of Pulmonary Fibrosis. Désogère, P., Tapias, LF., Rietz, TA., et al.[2020]

The developed probe, [68Ga]Ga·DOTA-CMP, effectively detects abnormal collagen in the lungs of a mouse model of idiopathic pulmonary fibrosis (IPF), indicating its potential for early diagnosis of the disease.

This probe shows high selective uptake in fibrotic lung tissue with minimal background signal in other organs, suggesting it could be a safe and effective tool for identifying IPF at an earlier stage when treatment may be more beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of Pulmonary Fibrosis with a Collagen-Mimetic Peptide. Borgula, IM., Shuvaev, S., Abston, E., et al.[2023]

CBP1495 is a newly identified collagen-binding peptide that effectively targets collagen type I, showing strong binding affinity and potential for use in imaging fibrosis.

The 99mTc-labelled version of CBP1495 demonstrated significant accumulation in fibrotic tissues in rat models, indicating its potential as a non-invasive radiotracer for diagnosing and monitoring fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular imaging of fibrosis using a novel collagen-binding peptide labelled with 99mTc on SPECT/CT. Zheng, L., Ding, X., Liu, K., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Type I collagen-targeted PET probe for pulmonary fibrosis detection and staging in preclinical models. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Biodistribution, Dosimetry, and Pharmacokinetics of 68Ga-CBP8: A Type I Collagen-Targeted PET Probe. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Optimization of a Collagen-Targeted PET Probe for Molecular Imaging of Pulmonary Fibrosis. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Detection of Pulmonary Fibrosis with a Collagen-Mimetic Peptide. [2023]

5. Austria pubmed.ncbi.nlm.nih.gov

Molecular imaging of fibrosis using a novel collagen-binding peptide labelled with 99mTc on SPECT/CT. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Improved Radiolytic Stability of a 68Ga-labelled Collagelin Analogue for the Imaging of Fibrosis. [2021]