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Integrin α6-targeted SPECT Imaging of Breast Cancer

Primary Purpose

Breast Cancer

Status

Completed

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

99mTc-RWY

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast cancer, integrin α6, SPECT

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Peking University Health Science Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

99mTc-RWY SPECT/CT

Arm Description

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.

Outcomes

Primary Outcome Measures

Blood Clearance

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

Excretion

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

Biodistribution

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

SPECT/CT imaging

Image brightness is observed。

Distributed in organs

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

Secondary Outcome Measures

Incidence of adverse events

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

Full Information

NCT ID

NCT04289532

First Posted

February 25, 2020

Last Updated

March 4, 2020

Sponsor

Peking University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04289532

Brief Title

Integrin α6-targeted SPECT Imaging of Breast Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

March 8, 2018 (Actual)

Primary Completion Date

June 1, 2019 (Actual)

Study Completion Date

June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast cancer, integrin α6, SPECT

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

99mTc-RWY SPECT/CT

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

99mTc-RWY

Other Intervention Name(s)

99mTc-labeled peptide targeting integrin α6

Intervention Description

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

Primary Outcome Measure Information:

Title

Blood Clearance

Description

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

Time Frame

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

Title

Excretion

Description

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

Time Frame

0-24 hours post-injection

Title

Biodistribution

Description

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

Time Frame

0.5,1,2,4,24 hours post-injection

Title

SPECT/CT imaging

Description

Image brightness is observed。

Time Frame

post-injection

Title

Distributed in organs

Description

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

Time Frame

0.5,1,2,4,24 hours post-injection

Secondary Outcome Measure Information:

Title

Incidence of adverse events

Description

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

Time Frame

1 week post-injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Peking University Health Science Center

City

Beijing

State/Province

Beijing

Country

China

12. IPD Sharing Statement

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Integrin α6-targeted SPECT Imaging of Breast Cancer

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