Integrated Positron Emission Tomography Magnetic Resonance (PET/MR) of Breast Cancer

NCT02766530 | Unknown Phase 4

• 1 other identifier: 201401091MINA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will use integrated PET/MR for the goals below:

1. 1.Use of PET-guided proton MRS (MR spectroscopy) and DCE MRI (dynamic contrast-enhanced MRI) for patients who will receive NAC (neoadjuvant chemotherapy) for breast cancer to monitor treatment response.
2. 2.Use of dynamic and static PET to monitor treatment response for NAC, and to investigate the correlation of PET results versus MRS, DCE MRI.
3. 3.Compare clinical staging by PET/MR and by clinical assessment.
4. 4.On pre-chemotherapy studies, to investigate the association of molecular marker status with the dynamic and static PET, MRS and DCE MRI parameters.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• treatment effect of neoadjuvant chemotherapy evaluated by positron emission tomography magnetic resonance (PET/MR)

  7 months for each patient

Secondary Outcomes (1)

• Clinical staging of pre-chemotherapy breast cancer by PET/MR

  12 months

Study Arms (1)

PETMR study

EXPERIMENTAL

All the study participants will receive PET MR examinations before neoadjuvant chemotherapy and during neoadjuvant chemotherapy (during early cycle as well as during mid-cycle of chemotherapy treatment). There will be two groups of patients after completion of neoadjuvant chemotherapy, that is, responders versus non-responders. We will compare the PET MR imaging parameters before, during neoadjuvant chemotherapy between the two groups of patients.

Other: PETMR study

Interventions

PETMR study OTHER

Use of PETMR study to evaluate the treatment response of breast cancer women

Also known as: MRI PET

PETMR study

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 25-75 years old.
• Women with recently diagnosed breast cancer and who will receive NAC to reduce tumor burden before surgery. (including locally advanced breast cancer (LABC) according to clinical assessment; or tumor size \> 2cm, that is, at least T2 in TNM staging).

You may not qualify if:

• Estimated GFR (eGFR) \< 60 mL/min/1.73 m2 and blood glucose \> 135 mg/dl; Past or present history of acute renal failure, renal dialysis, diabetes mellitus.
• Women who received metallic fixation, coronary artery stent in recent 3 months; or women who received mechanical valve replacement that is not compatible with MR magnet; or women with aneurysmal clips, pacemakers.
• Past history of claustrophobia.
• Women who are pregnant or who are planning to be pregnant, or who are lactating (though the possibility in our target population should be very low)
• Past history of breast cancer within recent 5 years before the currently diagnosed breast cancer.
• Women who received chemotherapy for other disease entity in recent 1 year.
• Women who cannot cooperate with the examinations.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Ruoh-Fang Yen, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruoh-Fang Yen, MD, PhD

CONTACT

886223123456; rfyen@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2016
• First Posted: May 9, 2016
• Study Start: July 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: May 9, 2016

Record last verified: 2016-05

Locations

TW (1)