Patients with breast cancer, IDC (n=3) and DCIS (n=3) scheduled for a lumpectomy.
Conditions
Interventions
Pharmaceutical Form: Powder for injection
Sponsors
NKI-AVL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Woman - Age > 58 - Histological proven breast cancer DCIS or IDC, cT1c cNx - Scheduled for breast tumour lumpectomy - IDC: Distance nipple to tumour marker (I125-seed) >5cm - Patiënten geven schriftelijk ‘informed consent’ Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 6 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: - A radioguided occult lesion localisation (ROLL) using Tc-99m - Administration of other Tc-99m pharmaceuticals 48 hours prior to surgery (with the exception of Tc-99m for the SN procedure in case of IDC) - Neo-adjuvant chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the present study is to assess the feasibility and image quality of high-resolution Tc99m-SestaMIBI imaging for detection, localisation, and quantification of resection margins in breast cancer specimens.;Primary end point(s): The main study endpoint is a series of high-resolution images of 6 breast cancer specimens. The images are visually scored for quality. • The outcome is that experienced specialist trained in the assessment of SPECT scans rate the image quality and determine if it is acceptable and useful. ;Secondary Objective: • Assess the accuracy of detection, localisation, and quantification of resection margins in breast cancer specimens imaged by U-SPECT+/CT. • Optimization of imaging using U-SPECT+/CT of tissue samples considering the dose, scan-time, acquisition, reconstruction, and filtering. • To obtain information about the I-125-seed as tumour marker in the breast cancer tumour in relation to the resection margins. ;Timepoint(s) of evaluation of this end point: This endpoint is determined after the acquisition and optimization of the SPECT/CT scan. After LVLS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Endpoint: Assessment of the margins takes place based on the obtained images. Areas with positive signal suspect for tumour explicitly in the area of the margins are communicated to the pathologist. By relating the pathology slices and images to the SPECT/CT images the image accuracy for margin detection are determined. o The outcome will be accuracy in mm and a visual determined correlation of pathology images with the SPECT/CT images. • Endpoint: By using the list mode of the U=SPECT and reconstruct images at different acquisition times a minimal injected dose can be determined. By the same list mode the optimal scan-time can also be evaluated. Acquisition, reconstruction, and filtering options can be compared to determine the optimal settings. o The outcome will be a minimal dose in MBq, a minimal scan-time, and the advised scan and reconstruction parameters. • Endpoint: The U-SPECT+/CT will image the SestaMIBI distribution within the specimen and the I-125 seed is visible too. A comparison between the SestaMIBI in the specimen, the I-125 seed, and the resection margins can be made. o Outcome values are the distance of the I-125-seed to the tumour border in mm, the distance between the centre of the tumour according to the SestaMIBI distribution and the location of the I-125-seed in mm. • Endpoint: The image quality of the preoperative images will determine if it is feasible and if further research is possible to use mobile gamma cameras for scintigraphic breast cancer imaging. o The level of lesion localisation (detection rate) and correlation to other imaging techniques will be the outcome of this secondary study parameter. ;Timepoint(s) of evaluation of this end point: All endpoints are evaluated after acquisition of the images. After LVLS | — |
Countries
Netherlands
Contacts
Public ContactInvestigator
NKI-AVL
Outcome results
None listed