None listed
Conditions
Brief summary
This study aims to evaluate novel imaging technologies to study breast cancers prior to and following neo-adjuvant chemotherapy. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or above who has previously untreated invasive breast cancer grade 1, 2, or 3. Study details Participants in this study will undergo novel imaging technologies in addition to standard care. This will comprise 3 scans, a MRI, FDG and FES PET/CT scan before starting neo-adjuvant chemotherapy and after the completion of neo-adjuvant chemotherapy. The MRI scans are performed according to routine care, with the participant lying on her stomach with breasts positioned in prone breast coils. The FDG and FLT scans are performed as a whole body scans with the particpant lying on her back, and a prone scan of the breasts. Particiapants need to fast for 4-6 hours prior to the PET/CT scans. Each scan will take approximately 30-45 minutes. These scans will enable us to assess and compare tumours on all imaging studies with pathological samples before and after chemotherapy. These data will provide clinicians with highly accurate functional, volumetric and spatial information. Ultimately, these studies will facilitate individualised treatment strategies, including de-escalation of surgery and radiation therapy.
Interventions
Additional non-standard of care cancer imaging will be conducted.
This will comprise MRI, FDG and FES PET/CT scans acquired pre- and post neo-adjuvant systemic therapies
MRI scans will be performed by medical imaging technologists. These scans take approximately 30 minutes.
PET/CT scans will be performed by nuclear medicine technologists. These scans take approximately 30 minutes each (plus a one hour preparation time).
4.0MBq/kg of FDG will be injected in the contra-lateral arm one hour prior
Additional non-standard of care cancer imaging will be conducted. This will comprise MRI, FDG and FES PET/CT scans acquired pre- and post neo-adjuvant systemic therapies MRI scans will be performed by medical imaging technologists. These scans take approximately 30 minutes. PET/CT scans will be performed by nuclear medicine technologists. These scans take approximately 30 minutes each (plus a one hour preparation time). 4.0MBq/kg of FDG will be injected in the contra-lateral arm one hour prior to each FDG scan. 2.5MBq/kg of FES will be injected in the contra-lateral arm one hour prior to each FES scan. Following intravenous administration of the tracers (FDG and FES), patients will rest for one hour prior to the scan. All scans will be performed at baseline (within four weeks prior to treatment) and after neoadjuvant systemic therapy (within two weeks prior to surgery).
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Written informed consent provided; • Female; • Minimum age 18 years, no maximum age; • Any menopausal status; • Primary tumour characteristics; o Histologically confirmed, previously untreated invasive breast carcinoma; o Unifocal or multifocal disease o Grade 1, 2 or 3; o ER positive in 10% of tumour cells by IHC; o HER2 positive; Either IHC 3+ (circumferential membrane staining that is complete, intense and in > 10% of tumour cells) or; ISH positive (average HER2 copy number 6.0 signals/cell, using single-signal (HER2 gene) assay) • Stage IIA - IIIB, American Joint Commission of Cancer (AJCC 8th edition); where primary tumour is T2 or T3 equal to or greater than 20mm (based on US of the breast); • Candidate for tri-modality treatment as per routine clinical practice (NAST + surgery + RT); • Willing and able to undergo additional study imaging; • ECOG performance status 0-1
Exclusion criteria
• Any previous systemic therapies (chemotherapy, aromatase inhibitors, immunotherapy), or thoracic/breast RT; • Hormonal replacement therapies (including oral HRT and IVF) within 30 days prior to study scans and during the study period; • FES PET contraindications, e.g. Total serum bilirubin > 1.5 times upper limit of normal (abnormal hepatic metabolism may interfere with FES hepatic excretion) tested < six weeks prior to scan; • MRI contraindications, e.g. ferromagnetic metallic implant; • Pregnant or lactating patients (due to whole body radioactive tracer dose).
Outcome results
None listed