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

NCT ID: NCT04596670

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-20

Study Completion Date

2025-12-31

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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Single Group Assignment
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

68Ga-ICAM-1pep

Intervention Type 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.

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

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

Group Type EXPERIMENTAL

68Ga-ICAM-1pep

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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68Ga-CD54pep

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Health Science Center

OTHER

Sponsor Role collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role lead

Responsible Party

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Hua Zhu

Principal Investigator and Vice Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhi Yang, Ph.D

Role: STUDY_CHAIR

Peking University Cancer Hospital & Institute

Hua Zhu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ting Zhang

Role: CONTACT

+8610-82802893

Facility Contacts

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Shunlian Zhou

Role: primary

References

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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.

Reference Type DERIVED
PMID: 33785590 (View on PubMed)

Other Identifiers

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2020KT112

Identifier Type: -

Identifier Source: org_study_id

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