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| Name | Class |
|---|---|
| Peking University Health Science Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting Zhang | Contact | +8610-82802893 | zhangt0183@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhi Yang, Ph.D | Peking University Cancer Hospital & Institute | Study Chair |
| Hua Zhu, Ph.D | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33785590 | Derived | 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Single Group Assignment
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