Breast-Specific Gamma Imaging and Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy

NCT02556684 | Unknown DMC

• 1 other identifier: BSGILAB001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Keywords

Breast-Specific Gamma Imaging; Locally Advanced Breast Cancer; Neoadjuvant Chemotherapy; BSGI

Outcome Measures

Primary Outcomes (1)

• Sensitivity/Specificity

  BSGI have a high sensitivity/specificity t in predicting which LABC patients achieve a complete pathologic response (pCR) following neo-adjuvant chemotherapy

  2 YEARS

Secondary Outcomes (2)

• pathologic complete response

  2 YEARS

• Overall Survival

  2 YEARS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

Cancer institute

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (5)

• Gong 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 BACKGROUND

• Kelley 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 BACKGROUND

• Yoon 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 BACKGROUND

• Lee 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 BACKGROUND

• Sun 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 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jian Huang, Dr

  Second Affiliated Hospital of Zhejiang University School of Medicine

  STUDY CHAIR

Central Study Contacts

Jian Huang, Dr

CONTACT

8657187315009; drhuangjiang@zju.edu.cn

Zhigang Zhang, Dr

CONTACT

8657187315009; zzg2011@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 11, 2015
• First Posted: September 22, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: April 11, 2019

Record last verified: 2019-04

Locations

CN (1)