99mTc-MIBI SPECT/CT in Breast Malignancy

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Device: SPECT/CT

• Registration Number: NCT00804544
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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.

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-12-04
• Study First Submitted QC: 2008-12-08
• Study First Posted: 2008-12-09
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-02
• Last Update Posted: 2012-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	SPECT/CT	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.

Primary Outcome Measures

Name	Time	Method
1- Nodal staging 2- Prediction of chemosensitivity 3- Evaluation of chemosensitivity	1 year

Secondary Outcome Measures

Name	Time	Method
Added-Value of integrated SPECT/Low-dose MultiSlice CT versus planar/SPECT imaging in mammoscintigraphy with 99mTc-SestaMIBI	1 year

Trial Locations

Locations (1)

South Street Hospital - Department of Nuclear Medicine; 🇨🇦 London, Ontario, Canada