Clinical trial · Interventional
99mTc-MIBI SPECT/CT in Breast Malignancy
Tc-99m Sestamibi SPECT/CT for Prediction of the Response of Locally Advanced Breast Malignancy to Neoadjuvant Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 4 patients have been enrolled into the pilot study. No complications reported. Another clinical trial has been designed.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SPECT/CT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- 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.
- interventionNames
- Device: SPECT/CT
Primary outcomes (1)
- measure
- 1- Nodal staging 2- Prediction of chemosensitivity 3- Evaluation of chemosensitivity
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- Added-Value of integrated SPECT/Low-dose MultiSlice CT versus planar/SPECT imaging in mammoscintigraphy with 99mTc-SestaMIBI
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (11)
- BACKGROUNDMoretti 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
- BACKGROUNDSpanu 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
- BACKGROUNDMaini 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
- BACKGROUNDTakamura 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
- BACKGROUNDDel 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
- BACKGROUNDSciuto 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
- BACKGROUNDKhalkhali 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.