Validation of (semi)quantitative metabolic SPECT/CT for therapy monitoring in Locally Advanced Breast Cancer: A Feasibility Study

Validation of (semi)quantitative metabolic SPECT/CT for therapy monitoring in Locally Advanced Breast Cancer: A Feasibility Study - Quantitative SPECT/CT in LABC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47441

Enrollment

Registered

2018-12-04

Start date

2017-08-22

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced breastcancer Locally advanced Mamma carcinoma

Interventions

LABC

SPECT/CT

therapy monitoring

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * Women * 18 years old * Proven LABC with at least one index lesion * 2 cm, scheduled for NAC and/or other systematic treatment * Clinical indication for BSGI

Exclusion criteria

Exclusion criteria: * Pregnancy * Proven BC with index lesion

Design outcomes

Primary

Measure	Time frame
Endpoint: Validation of 99mTc-sestamibi-based (semi)quantitative metabolic SPECT/CT parameters like standardized uptake value (SUVSPECT), metabolic tumour volume (MTVSPECT), total lesion mitochondrial uptake (TLMU), lesion wash-out (LWO) and tumour to background ratio (T/B), using a quantitative SPECT image reconstruction technique (QMetrix®), for therapy monitoring purposes in patients with LABC Outcome measures: - Percentage of BC patients in whom the above mentioned parameters can be technically measured using Q.Metrix® quantitative image reconstruction and SPECT/CT in hanging breast mode; - Actual measured (semi)quantitative data concerning the above mentioned metabolic tumour parameters; - Reproducibility analysis of these (semi)quantitative findings.	—

Measure

Time frame

Endpoint: Validation of 99mTc-sestamibi-based (semi)quantitative metabolic SPECT/CT parameters like standardized uptake value (SUVSPECT), metabolic tumour volume (MTVSPECT), total lesion mitochondrial uptake (TLMU), lesion wash-out (LWO) and tumour to background ratio (T/B), using a quantitative SPECT image reconstruction technique (QMetrix®), for therapy monitoring purposes in patients with LABC Outcome measures: - Percentage of BC patients in whom the above mentioned parameters can be technically measured using Q.Metrix® quantitative image reconstruction and SPECT/CT in hanging breast mode; - Actual measured (semi)quantitative data concerning the above mentioned metabolic tumour parameters; - Reproducibility analysis of these (semi)quantitative findings.

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Secondary

Measure	Time frame
Endpoint:To evaluate hanging breast acquisition mode using SPECT/CT in relation to the following aspects: timing, patient comfort, image quality, (semi)quantitative parameters. Outcome measures: - Subjective scoring of patient comfort (patient opinion) and image quality (investigator opinion) on a 3-point scale; - Percentage of patients in whom the index tumour can be visualised on the early SPECT/CT images, related to lesion diameter/volume; - Percentage of patients in whom the index tumour can be visualised on the late SPECT/CT images, related to lesion diameter/volume; - Percentage of patients in whom lesion wash-out can be measured by performing SPECT/CT acquisitions at 5 and 90 min after tracer injection Endpoint: To determine the feasibility of intratumoural heterogeneity analysis using visual scoring and quantitative textural lesion assessment. Outcome measures: - Visual measurement of heterogeneity in breast tumours using a 4-point scale (0: none; 1: mild; 2: moderate; 3: high); - Percentage of patients in whom quantitative textural lesion assessment can be technically performed, related to tumour size (diameter and volume) Endpoint: To explore if the (semi)quantitative parameters correlate with the pathological and radiological response to NAC and/or other systemic treatments. Outcome measures: - No response to NAC according to histopathology: residual tumour size reduced 75% compared to baseline clinical tumour size. - Histopathological response will be further graded using residual tumour cellularity. - Radiological response to NAC according to RECIST criteria.	—

Measure

Time frame

Endpoint:To evaluate hanging breast acquisition mode using SPECT/CT in relation to the following aspects: timing, patient comfort, image quality, (semi)quantitative parameters. Outcome measures: - Subjective scoring of patient comfort (patient opinion) and image quality (investigator opinion) on a 3-point scale; - Percentage of patients in whom the index tumour can be visualised on the early SPECT/CT images, related to lesion diameter/volume; - Percentage of patients in whom the index tumour can be visualised on the late SPECT/CT images, related to lesion diameter/volume; - Percentage of patients in whom lesion wash-out can be measured by performing SPECT/CT acquisitions at 5 and 90 min after tracer injection Endpoint: To determine the feasibility of intratumoural heterogeneity analysis using visual scoring and quantitative textural lesion assessment. Outcome measures: - Visual measurement of heterogeneity in breast tumours using a 4-point scale (0: none; 1: mild; 2: moderate; 3: high); - Percentage of patients in whom quantitative textural lesion assessment can be technically performed, related to tumour size (diameter and volume) Endpoint: To explore if the (semi)quantitative parameters correlate with the pathological and radiological response to NAC and/or other systemic treatments. Outcome measures: - No response to NAC according to histopathology: residual tumour size reduced 75% compared to baseline clinical tumour size. - Histopathological response will be further graded using residual tumour cellularity. - Radiological response to NAC according to RECIST criteria.

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)