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

NCT04596670 | Recruiting Early Phase 1 DMC

• 1 other identifier: 2020KT112
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

PET/CT; Radiotherapy; ICAM-1; 68Ga labeling

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

68Ga-ICAM1-1pep PET/CT in cancer patients before radiotherapy

EXPERIMENTAL

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-ICAM1-1pep PET/CT in cancer patients after radiotherapy

EXPERIMENTAL

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

Interventions

68Ga-ICAM-1pep DRUG

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.

Also known as: 68Ga-CD54pep

68Ga-ICAM1-1pep PET/CT in cancer patients after radiotherapy; 68Ga-ICAM1-1pep PET/CT in cancer patients before radiotherapy

Eligibility Criteria

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

You may qualify if:

• years old;
• ECOG score 0 or 1 point;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead
• Peking University Health Science Center: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 33785590 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Zhi Yang, Ph.D

  Peking University Cancer Hospital & Institute

  STUDY CHAIR

• Hua Zhu, Ph.D

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Zhang

CONTACT

+8610-82802893; zhangt0183@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Vice Director

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 22, 2020
• Study Start: September 20, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)