99mTc-3PRGD2 SPECT/CT in Breast Cancer Patients

NCT02742168 | Completed DMC

• 1 other identifier: FirstAHFujian2
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label SPECT/CT (single photon emission computed tomography / computed tomography) study to investigate clinical study of 99mTc-3PRGD2 SPECT/CT in diagnosis and efficacy evaluation of breast cancer. Diagnostic group: for patients in suspicion of breast cancer. The standard of truth for diagnosis was based on histopathologic findings after surgical removal of the tumor or a definite diagnosis from fine needle aspiration biopsy. A single dose of nearly 0.3 mCi/kg (milli-Curie/kilogram) body weight of 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the patients. Visual and semiquantitative method will be used to assess the whole-body planar and lesions SPECT/CT images. Efficacy evaluation group: for patients firstly diagnose with malignant tumors (breast cancer), and prepare to chemotherapy(including neoadjuvant chemotherapy) or radiotherapy. The standard of truth for diagnosis was based on histopathologic findings after fine needle aspiration biopsy. A single dose of nearly 0.3 mCi/kg body weight of 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the patients before treatment, the second period, sixth period. Visual,semiquantitative method will be used to assess the whole-body planar and lesions SPECT/CT images. By comparing with result of the other related imaging, for instance, PET/CT (positron emission tomography/computed tomography), CT (computed tomography), MRI (magnetic resonance imaging), Doppler Ultrasound, Mammography, etc.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Visual Assessment of Breast Lesions in 99mTc-3PRGD2 SPECT/CT Scan

  Visual analysis will be performed by 3 experienced nuclear medicine physicians to observe the the uptake of 99mTc-3PRGD2 on breast lesions. The visual analysis interpreter's degree of suspicion for an abnormality was recorded with use of a 3-point with the following categories: score 1, no abnormal increased uptake; score 2, mildly increased uptake; score 3, definite focal increased uptake. The lesion was considered positive as malignancy if the lesion scored as 2 or higher.

  One year

• Semiquantitative Assessment of Breast Lesions in 99mTc-3PRGD2 SPECT/CT Scan

  The semiquantitative analysis of the standardized uptake values (SUV) of 99mTc-3PRGD2 SPECT/CT was performed on breast lesion.

  One year

Secondary Outcomes (4)

• Adverse events collection

  5 days

• Mammography and/or ultrasound

  One year

• 18F-FDG PET/CT scan

  One year

• carbohydrate antigen 153

  One year

Study Arms (1)

Breast Cancer,99mTc-3PRGD2,SPECT/CT

EXPERIMENTAL

Determine if 99mTc-3PRGD2 SPECT/CT is safe and effective in diagnosis and efficacy evaluation of breast cancer

Radiation: 99mTc-3PRGD2

Interventions

99mTc-3PRGD2 RADIATION

Diagnostic group：For patients in suspicion of breast cancer, single intravenous bolus injection of nearly 0.3 mCi/kg body weight of 99mTc-3PRGD2 on day one of the treatment period, whole-body planar and lesions SPECT/CT to determine the accumulation of 99mTc-3PRGD2 in the tumors and the other parts of the body. Efficacy evaluation group：patients firstly diagnose with malignant lesions ,and prepare to chemotherapy(including neoadjuvant chemotherapy) or radiotherapy.the same dose of 99mTc-3PRGD2 will be intravenously injected into the patients before treatment ,the second period,the sixth period( almost three months after the initial treatment)，whole-body planar and lesions SPECT/CT to assess the value of 99mTc-3PRGD2 in evaluation of cancers.

Also known as: 99mTc-HYNIC-3PRGD2

Breast Cancer,99mTc-3PRGD2,SPECT/CT

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, ≥20 years old.
• Part of lesion CT and/or 18F-FDG PET/CT and/or MRI and/or Doppler Ultrasound and/or Mammography diagnosis in suspicion of primary or recurrent breast cancer.
• The above cancers will be histologically confirmed or results of histology will be available.

You may not qualify if:

• Females planning to bear a child recently or with childbearing potential.
• Known severe allergy.
• Inability to lie still for the entire imaging time because of cough, pain, etc.
• Inability to complete the needed examinations due to severe claustrophobia,radiation phobia, etc.
• Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.
• Efficacy evaluation group:
• Males and females, ≥20 years old.
• Firstly and definitely diagnose with malignant tumors ,and prepare to chemotherapy (including neoadjuvant chemotherapy) or radiotherapy.
• There are available lesions for assessment during the trial.
• Part of lesion CT and/or 18F-FDG PET/CT and/or MRI and/or Doppler Ultrasound and/or Mammography examination before treatment, the mid tern treatment, post-treatment( three months after the initial treatment) are available.
• Females planning to bear a child recently or with childbearing potential.
• Known severe allergy or hypersensitivity to IV radiographic contrast.
• Inability to lie still for the entire imaging time because of cough, pain, etc.
• Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
• Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

Related Publications (1)

• Chen Z, Fu F, Li F, Zhu Z, Yang Y, Chen X, Jia B, Zheng S, Huang C, Miao W. Comparison of [99mTc]3PRGD2 Imaging and [18F]FDG PET/CT in Breast Cancer and Expression of Integrin alphavbeta3 in Breast Cancer Vascular Endothelial Cells. Mol Imaging Biol. 2018 Oct;20(5):846-856. doi: 10.1007/s11307-018-1178-y.

  PMID: 29497956 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Weibing Miao, MD

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Nuclear Medicine

Model Details: The participants were underwent the 99mTc-3PRGD2 imaging and 18F-FDG imaging within one week.

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: April 18, 2016
• Study Start: January 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: August 3, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)