99mTc-MIBI SPECT/CT in Breast Malignancy

This study has been terminated.
(4 patients have been enrolled into the pilot study. No complications reported. Another clinical trial has been designed.)
Sponsor:
Collaborator:
University of Western Ontario, Canada
Information provided by (Responsible Party):
Irina Rachinsky, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00804544
First received: December 4, 2008
Last updated: March 2, 2012
Last verified: March 2012
  Purpose

99mTc-SestaMIBI mammoscintigraphy (MMS) may be used in patients with locally advanced breast cancer (LABC) scheduled for neoadjuvant chemotherapy. MMS may be performed for 1) nodal staging of axillary lymph node metastases, 2) prediction of chemosensitivity or Pgp/MDR-1 mediated chemoresistance, and 3) evaluation of efficacy to chemotherapy and radiation therapy.

MMS is routinely performed with planar/SPECT imaging according to the Society of Nuclear Medicine and European Association of Nuclear Medicine guidelines.

In this pilot study, an optimised acquisition protocol will be setup with SPECT/low-dose multislice CT in addition to planar imaging.


Condition Intervention
Breast Cancer
Device: SPECT/CT

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tc-99m Sestamibi SPECT/CT for Prediction of the Response of Locally Advanced Breast Malignancy to Neoadjuvant Chemotherapy

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • 1- Nodal staging 2- Prediction of chemosensitivity 3- Evaluation of chemosensitivity [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Added-Value of integrated SPECT/Low-dose MultiSlice CT versus planar/SPECT imaging in mammoscintigraphy with 99mTc-SestaMIBI [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: September 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Mammoscintigraphy with SPECT-CT optimized 99mTc-MIBI imaging (experimental arm) will be compared to conventional planar imaging. Mammoscintigraphy results before and after chemotherapy and radiation therapy, will be compared to the histopathological results after surgery.
Device: SPECT/CT
SPECT/Low-Dose MultiSclice CT
Other Name: Integrated SPECT/CT; Hybrid imaging

Detailed Description:

99mTc-SestaMIBI is a lipophylic cation as many cytotoxic chemotherapy drugs (i.e. anthracyclines, inhibitor of topoisomerase II, antimicrotubule, vinca alkaloids, inhibitors of DNA replication) accumulating in the mitochondria of tumour cells. MIBI tumour uptake is related to viability and proliferation due to increased perfusion and increased energy-dependent metabolism.

99mTc-SestaMIBI is a substrate for the glycoprotein P (Pgp) pump encoded by the multidrug resistance gene -1 (MDR-1). MIBI tumour uptake with no significant wash-out over time (<45% at 3H) predicts a chemosensitivity with no Pgp/MDR-1 overexpression. MIBI efflux with no significant tumour uptake predicts efflux of chemotherapy drugs from the tumour cells related to Pgp/MDR-1 overexpression or to anti-apoptotic Bcl-2 overexpression. Early MIBI efflux (< 1H) may also be related to pro-apoptotic Bax overexpression.

SPECT/CT will be used for anatomic localisation and and attenuation correction. CT from SPECT/CT is a low-dose (< 2 mSv) multislice CT (4 slice). SPECT/CT will also be used for correction of image-degrading factors including collimator-detector-response compensation for resolution recovery, and scatter correction. SPECT/CT based absolute semi-quantification of MIBI uptake into primary tumour and lymph nodes (i.e. standardised uptake value or SUV) will also be performed.

SPECT/CT optimised imaging will be compared to planar/SPECT conventional nuclear imaging for 1) detection of MIBI-avid primary breast tumour and lymph node metastases, 2) semi-quantification of MIBI uptake (T/B, SUV, and %wash-out) into primary breast tumour and lymph node metastases, 3) prediction of chemosensitivity at baseline, 3) Evaluation of chemotherapy efficacy after the first course of chemotherapy (after 2 weeks) compared to clinical response and histo-pathological response.

SPECT/CT mammoscintigraphy findings will be compared to clinical findings (palpation), radiological findings (mammography, US, MRI), and histo-pathological findings (Pgp/MDR-1 expression) into tumours after surgery.

  Eligibility

Ages Eligible for Study:   25 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically proven breast cancer
  • Patients with locally advanced breast cancer (stages T2-4 N0-3 M0)
  • Patients scheduled for neoadjuvant chemotherapy
  • Patients scheduled for radical modified mastectomy
  • Patients with no physical and/or psychological contraindications
  • Patients with no recent nuclear medicine study using long-lived isotopes (i.e. 67Ga, 111In, 131I) within the 48 hour preceding the mammoscintigraphy

Exclusion Criteria:

  • Patient with no histologically proven breast cancer
  • Patients with early stage T1 breast cancer
  • Patients who are not candidates for neoadjuvant chemotherapy
  • Patients who are not surgical candidates
  • Patients with physical and/or psychological contraindications
  • Pregnant or breast feeding patients
  • Patients with a recent nuclear medicine study using long-lived isotopes (i.e. 67Ga, 111In, 131I) within the 48 hour preceding the mammoscintigraphy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804544

Locations
Canada, Ontario
South Street Hospital - Department of Nuclear Medicine
London, Ontario, Canada, N6A 4G5
Sponsors and Collaborators
Lawson Health Research Institute
University of Western Ontario, Canada
Investigators
Principal Investigator: Irina Rachinsky, MD, MSc The UWO - LHSC - Department of Nuclear Medicine
Study Chair: Albert A Driedger, MD, PhD The UWO -LHSC - Department of Nuclear Medicine
Study Director: Muriel Brackstone, MD The UWO - LHSC - Department of General Surgery
Study Director: Francisco Perera, MD The UWO - LHSC - Department of Medical Oncology
  More Information

Additional Information:
Publications:

Responsible Party: Irina Rachinsky, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00804544     History of Changes
Other Study ID Numbers: R-08-383, 12967
Study First Received: December 4, 2008
Last Updated: March 2, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Integrated SPECT/CT
99mTc-sestMIBI
Chemosensitivity

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 14, 2014