Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury

NCT04485286 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 2020P001899R44CA250771K08CA259626
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to investigate the efficacy of \[68Ga\]CBP8 to detect collagen deposition in radiation induced tissue injury.

Conditions

Lung Cancer; Radiation Fibrosis; Radiation Induced Lung Injury; Pancreas Cancer

Keywords

fibrosis; positron emission tomography

Outcome Measures

Primary Outcomes (1)

• Ability of [68Ga]CBP8 to detect collagen deposition in areas of radiation injury.

  Probe uptake will be measured in lung cancer or pancreatic cancer patients 1) prior to radiation therapy and 2) 3-6 months after radiation therapy. We expect \[68Ga\]CBP8 signal to be increased in post radiation measurements over pre-radiation measurements in areas of irradiated tissue. Furthermore we expect that these areas will go on to develop radiation fibrosis.

  3-6 Months

Study Arms (1)

Lung Cancer or Pancreatic Cancer Subjects Undergoing Radiation Therapy

EXPERIMENTAL

Lung cancer or pancreatic cancer patients will receive \[68Ga\]CBP8 and undergo PET imaging 1) prior to radiation therapy and 2) 3-6 months after radiation therapy

Drug: [68Ga]CBP8

Interventions

[68Ga]CBP8 DRUG

Up to 15 mCi of \[68Ga\]CBP8 will be administered to each subject. Each subject will undergo baseline imaging prior to radiation and again 3-6 months after radiation therapy.

Lung Cancer or Pancreatic Cancer Subjects Undergoing Radiation Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients will be those harboring locally advanced clinical stage I-III NSCLC who are not eligible for surgical resection, or those with 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.
• Age ≥ 18 years.
• Life expectancy of greater than 3 months.
• Ability to understand and the willingness to sign a written informed consent document.
• Histologically or cytologically confirmed diagnosis of PDAC.
• Tumor should be confirmed with imaging based on the standard-of-care baseline abdominal CT performed within 1 month before study visit 1.
• Core samples for initial diagnosis must be available at the Department of Pathology at Massachusetts General Hospital.
• Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational imaging and standard treatment regimen are eligible for this trial.
• Scheduled study visit 1 within 1 month prior to starting neoadjuvant chemoradiotherapy (CRT)
• Subjects undergo neoadjuvant chemotherapy followed by radiotherapy (CRT) as part of their standard clinical care and based on institutional standards.
• Scheduled surgical pancreas resection within 1 month after post-CRT study visit.
• Subjects are required to undergo pre-surgical CT of abdomen within 1 month after completion of standard neoadjuvant CRT as part of routine clinical work-up.

You may not qualify if:

• 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 lung cancer or smoking related lung disease,)
• Pneumonia or other acute respiratory illness within 6 weeks of study entry, pneumonia defined with elevated WBC, fever, infiltrate on CXR and need for antibiotics
• History of radiotherapy to the upper abdomen in the past.
• History of reaction to MRI contrast (Gadoterate meglumine)
• Clinical or imaging diagnosis of acute pancreatitis within 6 weeks prior to study visit
• Participants with uncontrolled intercurrent illness or if determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening and/or during study).
• Participants with psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 31161770 BACKGROUND

• Desogere P, Tapias LF, Rietz TA, Rotile N, Blasi F, Day H, Elliott J, Fuchs BC, Lanuti M, Caravan P. Optimization of a Collagen-Targeted PET Probe for Molecular Imaging of Pulmonary Fibrosis. J Nucl Med. 2017 Dec;58(12):1991-1996. doi: 10.2967/jnumed.117.193532. Epub 2017 Jun 13.

  PMID: 28611243 BACKGROUND

• 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.

  PMID: 28381537 BACKGROUND

• Abston E, Zhou IY, Saenger JA, Shuvaev S, Akam E, Esfahani SA, Hariri LP, Rotile NJ, Crowley E, Montesi SB, Humblet V, Arabasz G, Catana C, Fintelmann FJ, Caravan P, Lanuti M. Noninvasive Quantification of Radiation-Induced Lung Injury using a Targeted Molecular Imaging Probe. medRxiv [Preprint]. 2023 Sep 26:2023.09.25.23295897. doi: 10.1101/2023.09.25.23295897.

  PMID: 37808864 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Radiation Fibrosis Syndrome; Pancreatic Neoplasms; Fibrosis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Radiation Injuries; Wounds and Injuries; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Michael Lanuti, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Shadi Esfahani, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Lanuti, MD

CONTACT

6176430193; mlanuti@mgh.harvard.edu

Shadi Esfahani, MD

CONTACT

AbdarEsfahani.Shadi@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Model Details: Eligible subjects planning on receiving radiation for lung cancer or pancreatic cancer will be enrolled to undergo imaging with the PET Probe \[68Ga\]CBP8.

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 24, 2020
• Study Start: July 19, 2020
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)