Integrin α6-targeted SPECT Imaging of Breast Cancer

NCT ID: NCT04289532

Last Updated: 2020-03-06

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

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-08

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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99mTc-RWY SPECT/CT

Volunteers and patients were injected intravenously with 11.1 MBq/kg of 99mTc-RWY in one dose and underwent SPECT/CT scan 30-60 min later.

Group Type EXPERIMENTAL

99mTc-RWY

Intervention Type DRUG

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

Interventions

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99mTc-RWY

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

Intervention Type DRUG

Other Intervention Names

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99mTc-labeled peptide targeting integrin α6

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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China-Japan Union Hospital, Jilin University

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role collaborator

Peking University

OTHER

Sponsor Role lead

Responsible Party

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Fan Wang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University Health Science Center

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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010006

Identifier Type: -

Identifier Source: org_study_id

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