This phase IIb pilot study will enrol 20 patients (women) presenting with metastatic breast cancer (ER/PR + HER2- on histology) who require imaging for staging or re-staging of their disease.
There is little published literature evaluating the usefulness of Ga Bombesin-PET imaging in comparison to currently accepted imaging modalities for detecting progressive metastatic breast cancer. This study aims to produce preliminary research to evaluate its clinical value in breast cancer, given the promising previously published cell line and mouse work in ER/PR+ HER2- tumours. It further aims to ascertain the theranostic potential of the NeoB peptide in the ER/PR + Her 2- population, particularly assessing the level of heterogeneity at sites of active malignancy compared to FDG PET. This study will add PET CT imaging using a tracer agent (NeoB) that directly targets the breast cancer cell. The ability of this new PET CT scan to detect sites of metastatic disease will be compared to standard procedures which include Diagnostic CT, bone scan and 18F-FDG PET. All patients will undergo a single time point imaging at Day 0 with PET CT to be conducted 120 (+/- 30) minutes after intravenous administration with 68Ga NeoB (3.0MBq/kg).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
Is a positron emission tomography (PET) imaging agent, intended as a selection tool for \[177Lu\]Lu-NeoB treatment in patients with tumors overexpressing gastrin releasing peptide receptor (GRPR).
St Vincent's Hospital
Sydney, New South Wales, Australia
RECRUITINGAssessment of Diagnostic Accuracy using a standard of truth (Biopsy, response to treatment RECIST and correlate images)
Diagnostic accuracy will be assessed by comparing lesions found on 68Ga NeoB PET CT to lesions found on conventional imaging (including CT, bone scan, and 18F-FDG PET/CT). Correlating images by sensitivity, specificity, true positive and negative predictive value
Time frame: 2 years
Comparison of SUVmax/mean
To compare SUV max/mean of 68Ga- NeoB imaging to 18F-FDG PET CT in patients with metastatic ER/PR+ HER2- breast cancer.
Time frame: 2 years
Quantitative Variation in Lesion measuring total tumor volume and lesional intensity
By direct comparison of sites of known metastatic disease between 68Ga NeoB and conventional imaging. Assessing the presence and/or absence of lesions using SUVmax/SUVmean)
Time frame: 2 years
Comparison of variation in total tumour volume
To compare total tumour volume of 68Ga- NeoB imaging to 18F-FDG PET CT in patients with metastatic ER/PR+ HER2- breast cancer.
Time frame: 2 years
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