Clinical trial · Observational
A Prospective Study to Evaluate FDG-PET, Breast MRI, and Breast Ultrasonography in Monitoring Tumour Responses in Patients With Locally Advanced Breast Cancer (LABC) Undergoing Neoadjuvant Chemotherapy
A Prospective Study to Evaluate the Role of 2-[18F]Fluoro-2-deoxy-D-glucose (FDG)-Positron Emission Tomography (PET), Breast Magnetic Resonance Imaging (MRI), and Breast Ultrasonography in Monitoring Tumour 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)
The overall goal of this study is to determine how FDG-PET, breast MRI and breast ultrasound can be incorporated into the assessment of treatment responses in women with LABC undergoing neoadjuvant chemotherapy. A prospective cohort study will be conducted evaluating the ability of FDG-PET, breast MRI and breast ultrasound to detect the presence of residual tumour in patients with LABC who have completed treatment with neoadjuvant chemotherapy prior to mastectomy.
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 |
|---|---|---|---|
| Locally Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The primary outcomes are the sensitivity and specificity of physical examination, ultrasound, breast MRI and PET in predicting which patients have achieved a complete pathologic response (pCR) prior to undergoing surgery.
- timeFrame
- 5 years
Secondary outcomes (3)
- measure
- Comparison of mean SUV uptake on FDG-PET for patients with pCR versus patients without pCR following neoadjuvant chemotherapy
- timeFrame
- 5 years
- measure
- The size of the tumour measured by physical examination, breast ultrasound and MRI just prior to surgery will be compared to pathology tumour measurements found following mastectomy.
- timeFrame
- 5 years
- measure
- Retrospective modelling to assess whether imaging test midway through chemotherapy affect management decisions
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 nonmelanotic 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 (e.g. positive serum B-hCG pregnancy test). * Unable to lie supine for imaging with PET. * 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 PET.
References
Publications (0)
Data not yet available