E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with breast cancer, IDC (n=3) and DCIS (n=3) scheduled for a lumpectomy. |
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E.1.1.1 | Medical condition in easily understood language |
Patients with breast cancer, scheduled for surgery. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Het primaire doen van de studie is om de haalbaarheid en beeldkwaliteit van hoge resolutie Tc99m-SestaMIBI opnamen voor de detectie, lokalisatie en kwantificatie van resectie marges in borstkanker preparaten. |
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E.2.2 | Secondary objectives of the trial |
• 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.
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- Onderzoek naar de mogelijkheden voor het detecteren, lokaliseren en kwantificeren van resectie marges in borstkanker preparaten met U-SPECT+/CT. - Optimalisatie van beeldvorming met de U-SPECT+/CT van weefselfragmenten (parameters zoals toegediende dosis, scantijd, acquisitie, reconstructie en filtering). - Evaluatie van de locatie van het I125 bronnetje relatief ten opzichte van de tumor, en de relatie daarvan met de locatie van marges. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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’
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- Vrouw - Bewezen mammacarcinoom DCIS of IDC, cT1 cNx - Gepland voor lumpectomie - Leeftijd > 58 jaar - IDC: Afstand tepel-tumormarker >5cm - De patiënt moet instaat zijn “informed consent” te geven.
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E.4 | Principal 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
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- ROLL procedure met Tc-99m - Toediening van andere Tc-99m farmaca in 48u voor OK (uitgezonderd voor SN-procedure in de IDC groep) - Neo-adjuvante chemotherapie
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E.5 End points |
E.5.1 | 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.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
This endpoint is determined after the acquisition and optimization of the SPECT/CT scan. After LVLS. |
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E.5.2 | 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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
All endpoints are evaluated after acquisition of the images. After LVLS |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |