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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Drug: 68Ga-ICAM-1pep


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-ICAM1-1pep PET/CT in cancer patients before radiotherapy<br>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<br>* 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.<br>* Other names: 68Ga-CD54pep;|
| Experimental: 68Ga-ICAM1-1pep PET/CT in cancer patients after radiotherapy<br>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<br>* 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.<br>* Other names: 68Ga-CD54pep;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET/CT, Radiotherapy, ICAM-1, 68Ga labeling