68Ga-ICAM-1pep PET/CT in Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-ICAM-1pep.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
68Ga-ICAM-1pep PET/CT Imaging of Tumor Responses to Radiotherapy in Cancer Patients
Overview
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
- 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.
Primary outcome measures
- Quantitate the standardized uptake values (SUVs) of 68Ga-ICAM-1pep at baseline. [Time frame: At baseline]
- Characterize changes in the standardized uptake values (SUVs) of 68Ga-ICAM-1pep during radiotherapy. [Time frame: 3 to 4 weeks after beginning of radiotherapy]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Beijing Cancer Hospital — Beijing
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. PMID 33785590
Identifiers
NCT: NCT04596670 · 2020KT112