Study Results
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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TERMINATED
NA
4 participants
INTERVENTIONAL
2008-09-30
2010-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
SPECT/CT
SPECT/Low-Dose MultiSclice CT
Interventions
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SPECT/CT
SPECT/Low-Dose MultiSclice CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
90 Years
FEMALE
No
Sponsors
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University of Western Ontario, Canada
OTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Irina Rachinsky
Principal Investigator
Principal Investigators
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Irina Rachinsky, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
The UWO - LHSC - Department of Nuclear Medicine
Albert A Driedger, MD, PhD
Role: STUDY_CHAIR
The UWO -LHSC - Department of Nuclear Medicine
Muriel Brackstone, MD
Role: STUDY_DIRECTOR
The UWO - LHSC - Department of General Surgery
Francisco Perera, MD
Role: STUDY_DIRECTOR
The UWO - LHSC - Department of Medical Oncology
Locations
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South Street Hospital - Department of Nuclear Medicine
London, Ontario, Canada
Countries
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References
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Moretti JL, Hauet N, Caglar M, Rebillard O, Burak Z. To use MIBI or not to use MIBI? That is the question when assessing tumour cells. Eur J Nucl Med Mol Imaging. 2005 Jul;32(7):836-42. doi: 10.1007/s00259-005-1840-x.
Spanu A, Chessa F, Sanna D, Cottu P, Manca A, Nuvoli S, Madeddu G. Scintimammography with a high resolution dedicated breast camera in comparison with SPECT/CT in primary breast cancer detection. Q J Nucl Med Mol Imaging. 2009 Jun;53(3):271-80. Epub 2008 Jul 4.
Maini CL, Tofani A, Sciuto R, Semprebene A, Cavaliere R, Mottolese M, Benevolo M, Ferranti F, Grandinetti ML, Vici P, Lopez M, Botti C. Technetium-99m-MIBI scintigraphy in the assessment of neoadjuvant chemotherapy in breast carcinoma. J Nucl Med. 1997 Oct;38(10):1546-51.
Takamura Y, Miyoshi Y, Taguchi T, Noguchi S. Prediction of chemotherapeutic response by Technetium 99m--MIBI scintigraphy in breast carcinoma patients. Cancer. 2001 Jul 15;92(2):232-9. doi: 10.1002/1097-0142(20010715)92:23.0.co;2-g.
Del Vecchio S, Zannetti A, Ciarmiello A, Aloj L, Caraco C, Fonti R, Botti G, D'Aiuto G, Salvatore M. Dynamic coupling of 99mTc-MIBI efflux and apoptotic pathway activation in untreated breast cancer patients. Eur J Nucl Med Mol Imaging. 2002 Jun;29(6):809-14. doi: 10.1007/s00259-002-0773-x. Epub 2002 Mar 13.
Sciuto R, Pasqualoni R, Bergomi S, Petrilli G, Vici P, Belli F, Botti C, Mottolese M, Maini CL. Prognostic value of (99m)Tc-sestamibi washout in predicting response of locally advanced breast cancer to neoadjuvant chemotherapy. J Nucl Med. 2002 Jun;43(6):745-51.
Khalkhali I, Diggles LE, Taillefer R, Vandestreek PR, Peller PJ, Abdel-Nabi HH. Procedure guideline for breast scintigraphy. Society of Nuclear Medicine. J Nucl Med. 1999 Jul;40(7):1233-5. No abstract available.
Xu HB, Li L, Xu Q. Tc-99m sestamibi scintimammography for the diagnosis of breast cancer: meta-analysis and meta-regression. Nucl Med Commun. 2011 Nov;32(11):980-8. doi: 10.1097/MNM.0b013e32834b43a9.
Schillaci O, Danieli R, Filippi L, Romano P, Cossu E, Manni C, Simonetti G. Scintimammography with a hybrid SPECT/CT imaging system. Anticancer Res. 2007 Jan-Feb;27(1B):557-62.
Goldsmith SJ, Parsons W, Guiberteau MJ, Stern LH, Lanzkowsky L, Weigert J, Heston TF, Jones E, Buscombe J, Stabin MG; Society of Nuclear Medicine. SNM practice guideline for breast scintigraphy with breast-specific gamma-cameras 1.0. J Nucl Med Technol. 2010 Dec;38(4):219-24. doi: 10.2967/jnmt.110.082271. Epub 2010 Nov 5. No abstract available.
Bombardieri E, Aktolun C, Baum RP, Bishof-Delaloye A, Buscombe J, Chatal JF, Maffioli L, Moncayo R, Mortelmans L, Reske SN. Breast scintigraphy: procedure guidelines for tumour imaging. Eur J Nucl Med Mol Imaging. 2003 Dec;30(12):BP107-14. doi: 10.1007/s00259-003-1354-3. No abstract available.
Related Links
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The University of Western Ontario
Other Identifiers
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12967
Identifier Type: OTHER
Identifier Source: secondary_id
R-08-383
Identifier Type: -
Identifier Source: org_study_id
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