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

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

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04596670

Enrollment

Registered

2020-10-22

Start date

2024-09-20

Completion date

2025-12-31

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

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

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.

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.

Interventions

DRUG68Ga-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.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Single Group Assignment

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Quantitate the standardized uptake values (SUVs) of 68Ga-ICAM-1pep at baseline.	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.
Characterize changes in the standardized uptake values (SUVs) of 68Ga-ICAM-1pep during radiotherapy.	3 to 4 weeks after beginning of 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.

Countries

China

Contacts

Primary ContactTing Zhang

zhangt0183@bjmu.edu.cn+8610-82802893

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026