99mTc-MIBI SPECT/CT in Breast Malignancy

NCT00804544 | Terminated

• 2 other identifiers: R-08-38312967
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Integrated SPECT/CT; 99mTc-sestMIBI; Chemosensitivity

Outcome Measures

Primary Outcomes (1)

• 1- Nodal staging 2- Prediction of chemosensitivity 3- Evaluation of chemosensitivity

  1 year

Secondary Outcomes (1)

• Added-Value of integrated SPECT/Low-dose MultiSlice CT versus planar/SPECT imaging in mammoscintigraphy with 99mTc-SestaMIBI

  1 year

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

SPECT/CT DEVICE

SPECT/Low-Dose MultiSclice CT

Also known as: Integrated SPECT/CT; Hybrid imaging

1

Eligibility Criteria

• Age: 25 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• University of Western Ontario, Canada: collaborator

Study Sites (1)

South Street Hospital - Department of Nuclear Medicine

London, Ontario, N6A 4G5, Canada

Location

Related Publications (11)

• 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.

  PMID: 15902437 BACKGROUND

• 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.

  PMID: 18596669 BACKGROUND

• 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.

  PMID: 9379190 BACKGROUND

• 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.

  PMID: 11466674 BACKGROUND

• 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.

  PMID: 12029556 BACKGROUND

• 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.

  PMID: 12050317 BACKGROUND

• 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.

  PMID: 10405150 BACKGROUND

• 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.

  PMID: 21956488 BACKGROUND

• 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.

  PMID: 17348441 BACKGROUND

• 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.

  PMID: 21057112 BACKGROUND

• 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.

  PMID: 14989223 RESULT

Related Links

• The University of Western Ontario

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Single Photon Emission Computed Tomography Computed Tomography; Multimodal Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed, Single-Photon; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Irina Rachinsky, MD, MSc

  The UWO - LHSC - Department of Nuclear Medicine

  PRINCIPAL INVESTIGATOR

• Albert A Driedger, MD, PhD

  The UWO -LHSC - Department of Nuclear Medicine

  STUDY CHAIR

• Muriel Brackstone, MD

  The UWO - LHSC - Department of General Surgery

  STUDY DIRECTOR

• Francisco Perera, MD

  The UWO - LHSC - Department of Medical Oncology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 9, 2008
• Study Start: September 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: March 5, 2012

Record last verified: 2012-03

Locations

CA (1)