68Ga-ICAM-1pep PET/CT in Cancer Patients

68Ga-ICAM-1pep PET/CT Imaging of Tumor Responses to Radiotherapy in Cancer Patients

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the clinical predictive value of 68Ga-ICAM-1pep in metastatic cancer patients receiving radiotherapy. A single dose of 2.96 MBq/kg body weight of 68Ga-ICAM-1pep will be injected intravenously. The visual and semiquantitative methods will be used to assess the PET/CT images.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Drug: 68Ga-ICAM-1pep

Detailed Description

Radiotherapy has a systemic inhibitory effect on non-irradiated lesions (abscopal effect) in addition to local antitumor effects, and currently no biomarkers are used for the prediction of the abscopal effect of radiotherapy in standard clinical practice. Our recent preclinical studies identified ICAM-1 as a potential predictive biomarker for the radiotherapy-induced abscopal effect. In this clinical trial, we aim to investigate whether the ICAM-1-targeting radiotracer 68Ga-ICAM-1pep could be used for PET imaging of tumor responses to radiotherapy in cancer patients. PET/CT imaging of 68Ga-ICAM-1pep will be performed in patients before and after radiotherapy.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Ting Zhang; Phone Number: +8610-82802893; Email: zhangt0183@bjmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Shunlian Zhou; Email: zhoushunlian@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18-80 years old;
2. ECOG score 0 or 1 point;
3. Patients with suspected or confirmed lung cancer, esophagus cancer, cervical cancer or other cancers who are suggested by the clinicians to conduct PET/CT imaging for tumor diagnosis or staging.

Exclusion Criteria:

1. Pregnant or nursing;
2. Severe hepatic or renal dysfunction;
3. Low WBC (less than 3 x 10^9/L);
4. Unable to comply with the PET/CT imaging procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 68Ga-ICAM1-1pep PET/CT in cancer patients before radiotherapy; Cancer patients who have not undergone radiotherapy will be injected with 2.96 MBq/kg body weight of 68Ga-ICAM-1pep in one dose intravenously and then undergo PET/CT scan 1 h later. Interventions: Drug: 68Ga-ICAM-1pep Device: PET/CT	Drug: 68Ga-ICAM-1pep; 68Ga-ICAM-1pep PET/CT: after intravenous injection of 2.96 MBq/kg body weight of quality-controlled 68Ga-ICAM-1pep, a Siemens Biograph PET/CT scan will be applied within 1 h, and the scan range will be from the top of the head to 1/3 of the upper thigh.; Other Names: 68Ga-CD54pep
Experimental: 68Ga-ICAM1-1pep PET/CT in cancer patients after radiotherapy; Cancer patients post-radiotherapy will be injected with 2.96 MBq/kg body weight of 68Ga-ICAM-1pep in one dose intravenously and then undergo PET/CT scan 1 h later. Interventions: Drug: 68Ga-ICAM-1pep Device: PET/CT	Drug: 68Ga-ICAM-1pep; 68Ga-ICAM-1pep PET/CT: after intravenous injection of 2.96 MBq/kg body weight of quality-controlled 68Ga-ICAM-1pep, a Siemens Biograph PET/CT scan will be applied within 1 h, and the scan range will be from the top of the head to 1/3 of the upper thigh.; Other Names: 68Ga-CD54pep

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitate the standardized uptake values (SUVs) of 68Ga-ICAM-1pep at baseline.	Perform PET/CT imaging using 68Ga-ICAM-1pep before radiotherapy.The semiquantitative analysis will be performed by the same nuclear medicine physician for all cases, and the standardized uptake values (SUVs) of 68Ga-ICAM-1pep in the tumor lesions will be measured.	At baseline
Characterize changes in the standardized uptake values (SUVs) of 68Ga-ICAM-1pep during radiotherapy.	Perform PET/CT imaging using 68Ga-ICAM-1pep after radiotherapy. The semiquantitative analysis will be performed by the same nuclear medicine physician for all cases, and the standardized uptake values (SUVs) of 68Ga-ICAM-1pep in the tumor lesions will be measured. The SUVs of 68Ga-ICAM-1pep in the tumor lesions after radiotherapy will be compared with that at the baseline.	3 to 4 weeks after beginning of radiotherapy

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Collaborators: Peking University Health Science Center
• Investigators: Study Chair: Zhi Yang, Ph.D, Peking University Cancer Hospital & Institute; Principal Investigator: Hua Zhu, Ph.D, Peking University Cancer Hospital & Institute

Publications and helpful links

General Publications

• Zhao Y, Zhang T, Wang Y, Lu D, Du J, Feng X, Zhou H, Liu N, Zhu H, Qin S, Liu C, Gao X, Yang Z, Liu Z. ICAM-1 orchestrates the abscopal effect of tumor radiotherapy. Proc Natl Acad Sci U S A. 2021 Apr 6;118(14):e2010333118. doi: 10.1073/pnas.2010333118.

Study record dates

Study Major Dates

• Study Start (Estimated): September 20, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: PET/CT; Radiotherapy; ICAM-1; 68Ga labeling
• Other Study ID Numbers: 2020KT112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No