Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI) and Fluorothymidine Positron Emission Tomography (FLT PET) in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy (IMPACT)

Ontario Clinical Oncology Group (OCOG)

Status: Completed

Conditions: Locally Advanced Breast Cancer (LABC)

Treatments: Procedure: FLT PET and BOLD MRI scan

Study type: Interventional

Funder types: Other

Identifiers

NCT01240681

OCOG-2010-IMPACT

Details and patient eligibility

About

The objective of this pilot study is to determine the effectiveness of Fluorothymidine Positron Emission Tomography (FLT PET) and Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI) in assessing tumour response to neoadjuvant chemotherapy (NA CT) in women with locally advanced breast cancer.

Enrollment: 32 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic proof of breast cancer (invasive ductal or lobular carcinoma). Breast sarcoma and lymphoma are not eligible.
• Clinical diagnosis of locally advanced breast cancer (Stage IIB (T3,N0,M0), Stage IIIA, IIIB, or IIIC, according to American Joint Committee on Cancer (AJCC) Tumour-Node-Metastasis (TNM) Cancer Staging), including inflammatory breast cancer.
• Ability to undergo neoadjuvant chemotherapy.

Exclusion criteria

• Evidence of metastatic disease (identified on chest x-ray, liver ultrasound, bone scan or other imaging tests);
• Previous chemotherapy or hormonal therapy for breast cancer;
• Significant concurrent medical problems that result in the patient being unfit for surgery (e.g. uncontrolled diabetes, active cardiac disease, severe chronic obstructive pulmonary disease);
• Known pregnancy or lactating female (e.g. positive serum beta human chorionic gonadotropin (B-hCG) pregnancy test);
• Inability to lie supine for imaging with Positron Emission Tomography (PET);
• Any contraindication to undergoing Magnetic Resonance Imaging (MRI) or PET;
• Currently receiving Antabuse;
• Inability to provide informed consent (e.g. dementia or severe cognitive impairment).

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

32 participants in 1 patient group

FLT PET and BOLD MRI scan

Other group

Description:

All subjects will have the study intervention of FLT PET and BOLD MRI at baseline and after the first cycle of chemotherapy

Treatment:

Procedure: FLT PET and BOLD MRI scan