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NCT Number: NCT04596670

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location status: Recruiting

Location contact

Shunlian Zhou

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: 68Ga-CD54pep

Primary outcomes

  1. Quantitate the standardized uptake values (SUVs) of 68Ga-ICAM-1pep at baseline.

    Time frame: 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.

  2. Characterize changes in the standardized uptake values (SUVs) of 68Ga-ICAM-1pep during radiotherapy.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ting Zhang

CONTACT

[email protected]

+8610-82802893

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Collaborators

  • Peking University Health Science Center

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 22, 2020
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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