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NCT Number: NCT04289532

Integrin α6-targeted SPECT Imaging of Breast Cancer

A novel radiotracer 99mTc-RWY targeting Integrin α6 was developed, and the pilot first-in-human study for SPECT imaging of breast cancer was performed in seven healthy volunteers and two breast cancer patients to assess the safety and potential clinical applications of 99mTc-RWY.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Peking University Health Science Center

Beijing, Beijing Municipality, China

About this study

Integrin α6 associates with the survival and migration of breast cancer cells, which emerges as a predictor of reduced overall survival and worse prognosis. In this study, we developed an integrin α6-targeted radiotracer 99mTc-RWY for SPECT imaging of breast cancer. The safety, biodistribution and radiation dosimetry were studied in seven healthy volunteers, and the clinical potential of 99mTc-RWY was examined in two breast cancer patients. A single dose of 11.1 MBq/kg 99mTc-RWY was injected intravenously. Visual and semiquantitative methods were used to assess the SPECT/CT images. The routine Hematoxylin-Eosin (HE) staining and immunohistochemistry (IHC) staining were subsequently carried out to confirm the Integrin α6 expression of tumors.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers.
  • Body mass index (BMI) at 19 to 25 [Body mass index = body weight (kg)/ height squared (m2)];
  • Clinical laboratory tests (heart, liver, kidney, blood) indicators are in the normal range or abnormalities without clinical significance;
  • Informed written consents were obtained from all 9 subjects before the procedure.
  • Patients in suspicion of breast cancer by mammography or ultrasonography, and being able to provide basic information.

Exclution Criteria:

  • The investigator judged that it is not suitable for clinical trials based on the overall situation of the volunteers and patients.

Treatment and study plan

99mTc-RWY

Drug

99mTc-RWY were injected into volunteers and patients before the SPECT/CT scans .

Other names: 99mTc-labeled peptide targeting integrin α6

Primary outcomes

  1. Blood Clearance

    Time frame: 1,3,5,10,15,30,60,120 minutes post-injection

    The %ID (the radioactivity of the blood at each time period/the total injection activity) is calculated.

  2. Excretion

    Time frame: 0-24 hours post-injection

    The %ID (the radioactivity of the urine at each time period/the total injection activity) is calculated.

  3. Biodistribution

    Time frame: 0.5,1,2,4,24 hours post-injection

    Area under the activity-time curve from hour 0 to last measurable activity.

  4. SPECT/CT imaging

    Time frame: post-injection

    Image brightness is observed。

  5. Distributed in organs

    Time frame: 0.5,1,2,4,24 hours post-injection

    The %ID (the radioactivity of the main organs at each time period/the total injection activity) is calculated.

Secondary outcomes

  1. Incidence of adverse events

    Time frame: 1 week post-injection

    Adverse events within 1 week after the injection and scanning were followed and assessed.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Collaborators

  • China-Japan Union Hospital, Jilin University
  • Sun Yat-sen University

Registry information

Official study title

First-in-human Pilot Study of an Integrin α6-targeted Radiotracer for SPECT Imaging of Breast Cancer

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2020
Registry last updated
Mar 6, 2020

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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