Clinical trial · Observational
Breast-Specific Gamma Imaging and Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy
A Prospective Study to Evaluate Dynamic Breast-Specific Gamma Imaging in Monitoring Tumor Responses in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A prospective cohort study design will be conducted. Patients with LABC who receive chemotherapy will undergo physical examination, ultrasound, MRI, and BSGI at baseline, midway, and at the completion of chemotherapy. Approximately 100 patients will be recruited over a 2-year period. This study will give clinicians further insight into the usefulness of ultrasound, MRI, and BSGI in monitoring treatment responses in patients with LABC. This could potentially lead to changes in clinical management of these patients.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sensitivity/Specificity
- timeFrame
- 2 YEARS
- description
- BSGI have a high sensitivity/specificity t in predicting which LABC patients achieve a complete pathologic response (pCR) following neo-adjuvant chemotherapy
Secondary outcomes (2)
- measure
- pathologic complete response
- timeFrame
- 2 YEARS
- description
- BSCGI might changes in clinical management by identifying non-responders earlier than with other examinations.
- measure
- Overall Survival
- timeFrame
- 2 YEARS
- description
- BSGI predict long-term survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria * 18 Years and older, and histologic proof of breast cancer (invasive ductal or lobular carcinoma-not breast sarcoma or lymphoma) * Patients having a clinical diagnosis of locally advanced breast cancer (T3 or T4, or N2 according to TNM classification) including inflammatory breast cancer. * Patients must be able to undergo neoadjuvant chemotherapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 sufficient to undergo chemotherapy Exclusion Criteria * Previously treated cancer other than non melanotic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater. * Evidence of metastatic disease (found on chest X-ray, liver ultrasound or bone scan). * Previous chemotherapy or hormonal therapy for breast cancer. * Active infection or other significant illnesses which could hamper their ability to tolerate chemotherapy * Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac disease, severe chronic obstructive pulmonary disease) making the patient unfit for surgery. * Any condition that could interfere with their ability to provide informed consent such as dementia or severe cognitive impairment. * Pregnant or lactating females. * Inadequate hematologic, renal and liver function as measured by CBC (WBC\<4.0 x 109, Hb\<100 g/L, plt count\<100 x 109), and abnormal hepatic transaminases (AST, ALT, GGT, alkaline phosphatase\>2x normal), elevated total bilirubin, and elevated serum creatinine (Cr\>110 micromol/L). * Any contraindication to undergoing MRI or BSGI.
References
Publications (5)
- BACKGROUNDGong Z, Williams MB. Comparison of breast specific gamma imaging and molecular breast tomosynthesis in breast cancer detection: Evaluation in phantoms. Med Phys. 2015 Jul;42(7):4250-9. doi: 10.1118/1.4922398. PMID 26133623
- BACKGROUNDKelley KA, Crawford JD, Thomas K, Gardiner SK, Johnson NG. A Comparison of Breast-Specific Gamma Imaging of Invasive Lobular Carcinomas and Ductal Carcinomas. JAMA Surg. 2015 Aug;150(8):816-8. doi: 10.1001/jamasurg.2015.0965. No abstract available. PMID 26107618
- BACKGROUNDYoon HJ, Kim Y, Chang KT, Kim BS. Prognostic value of semi-quantitative tumor uptake on Tc-99m sestamibi breast-specific gamma imaging in invasive ductal breast cancer. Ann Nucl Med. 2015 Aug;29(7):553-60. doi: 10.1007/s12149-015-0977-3. Epub 2015 May 5. PMID 25939640
- BACKGROUNDLee HS, Ko BS, Ahn SH, Son BH, Lee JW, Kim HJ, Yu JH, Kim SB, Jung KH, Ahn JH, Cha JH, Kim HH, Lee HJ, Song IH, Gong G, Park SH, Lee JJ, Moon DH. Diagnostic performance of breast-specific gamma imaging in the assessment of residual tumor after neoadjuvant chemotherapy in breast cancer patients. Breast Cancer Res Treat. 2014 May;145(1):91-100. doi: 10.1007/s10549-014-2920-z. Epub 2014 Mar 27. PMID 24671359
- BACKGROUNDSun Y, Wei W, Yang HW, Liu JL. Clinical usefulness of breast-specific gamma imaging as an adjunct modality to mammography for diagnosis of breast cancer: a systemic review and meta-analysis. Eur J Nucl Med Mol Imaging. 2013 Feb;40(3):450-63. doi: 10.1007/s00259-012-2279-5. Epub 2012 Nov 14. PMID 23151912