[68Ga]CBP8 PET Imaging for Idiopathic Pulmonary Fibrosis

Overseen By Abimbola Akinniyi

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Massachusetts General Hospital

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging agent, [68Ga]CBP8, to determine its safety and effectiveness in detecting collagen build-up in the lungs, a sign of pulmonary fibrosis. The trial includes various groups: individuals with chronic lung issues post-transplant, immune-related lung inflammation, lung cancer, healthy volunteers, and those with pulmonary fibrosis. Suitable candidates have a history of lung problems, such as idiopathic pulmonary fibrosis or immune-checkpoint-inhibitor pneumonitis, and have not used tobacco recently. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new imaging agent.

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 prior data suggests that [68Ga]CBP8 is safe for PET imaging in pulmonary fibrosis?

Research has shown that [68Ga]CBP8 has been studied for its safety and ability to detect collagen build-up in lung diseases. Previous studies with animals and humans demonstrated that [68Ga]CBP8 can identify increased collagen in the lungs, particularly in people with idiopathic pulmonary fibrosis. This indicates the probe effectively finds areas with fibrosis.

Importantly, studies have examined how [68Ga]CBP8 travels through the body and where it accumulates in different tissues. These studies are crucial for understanding its safety. In human studies, no major side effects were reported, suggesting that the treatment is generally well-tolerated. However, since this trial is in its first phase, the main goal is to ensure the probe's safety in humans before conducting further tests. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about [68Ga]CBP8 because it offers a new way to visualize and understand idiopathic pulmonary fibrosis (IPF) using PET imaging. Unlike current treatments that primarily aim to slow disease progression, [68Ga]CBP8 acts as a diagnostic tool, allowing doctors to see how fibrosis develops in the lungs. This imaging agent specifically targets collagen, a key component in fibrosis, providing a clearer picture of the disease process. By improving our understanding of IPF, [68Ga]CBP8 could lead to more personalized and effective treatment strategies in the future.

What evidence suggests that [68Ga]CBP8 is effective for detecting collagen deposition in pulmonary fibrosis?

Research has shown that [68Ga]CBP8 effectively identifies collagen buildup in lungs with fibrosis. In animal studies, [68Ga]CBP8 detected lung fibrosis and performed well compared to healthy lungs, highlighting areas where lung tissue thickens. Early human studies also demonstrated its safety and ability to detect collagen in the lungs. In this trial, participants from various groups, including those with idiopathic pulmonary fibrosis, will receive [68Ga]CBP8 and undergo PET imaging. This imaging tool might help doctors assess fibrosis severity and potentially track changes over time. ^{1 2 3 4 6}

Who Is on the Research Team?

Sydney Montesi, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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

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

If you are in the healthy group, you have never used tobacco before.

Exclusion Criteria

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

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

Your body mass index (BMI) is higher than 33, which is the limit for the MRI table.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• [68Ga]CBP8

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.

How Is the Trial Designed?

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+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

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]

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]

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]

An improved collagelin analogue labeled with gallium-68 for PET imaging shows promise for non-invasive and sensitive assessment of fibrosis, achieving a high radiochemical purity of 98% and stable performance for at least 3 hours.

In studies with mice, the new imaging agent demonstrated specific binding to fibrotic liver tissue, correlating well with fibrosis severity, and exhibited a safe dosimetry profile allowing for multiple PET scans per year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Radiolytic Stability of a 68Ga-labelled Collagelin Analogue for the Imaging of Fibrosis. Velikyan, I., Rosenström, U., Rosestedt, M., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5568793/

Type I collagen-targeted PET probe for pulmonary fibrosis ... In this model, PET imaging of collagen with 68Ga-CBP8 successfully identified animals with pulmonary fibrosis, and additionally, detected blunted disease ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03535545

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

3. jnm.snmjournals.org jnm.snmjournals.org/content/64/5/775

Biodistribution, Dosimetry, and Pharmacokinetics of 68Ga-CBP8 The aim of this study was to determine the biodistribution, dosimetry, and pharmacokinetics of 68 Ga-CBP8 in healthy human subjects.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10152126/

Biodistribution, Dosimetry, and Pharmacokinetics of 68Ga ... 68 Ga-CBP8 is a promising probe for noninvasive imaging of collagen that might be applied to a range of fibrotic diseases.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04485286

Evaluation of PET Probe [68Ga]CBP8 in the Detection ... [68Ga]CBP8 showed high specificity for pulmonary fibrosis and high target:background ratios in diseased animals. In addition, [68Ga]CBP8 could be used to ...

6. advances.massgeneral.org advances.massgeneral.org/pulmonary/article.aspx?id=1297

New Molecular Imaging Tool Detects Pulmonary Fibrosis A new molecular imaging tool that recognizes type I collagen. The probe is being used to identify disease activity in pulmonary fibrosis and other conditions.