Primary objective: To assess accuracy and reproducibility of a new and innovative quantitative SPECT image reconstruction technique (QMetrix®) in locally advanced breast cancer. Secondary objectives: To evaluate:a) Hanging breast acquisition mode…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
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.
- 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.
Background summary
Breast cancer (BC) is the most common malignancy in women in developed
countries. Tumour resistance to neoadjuvant chemotherapy (NAC) is the major
cause of therapy failure. Therefore, early prediction of the response to NAC
may allow a switch to other drugs in non-responders, avoiding ineffective
chemotherapy and leading to more personalized treatment. The role of 18F-FDG
PET/CT to monitor NAC response remains unclear and is strongly influenced by
breast tumour subtypes. To date, 99mTc-methoxyisobutylisonitrile
(99mTc-Sestamibi or MIBI) is the most widely used non-PET radiotracer in BC.
MIBI allows in vivo assessment of tumour chemoresistance and appears to early
identify those patients who would benefit from alternative treatment. However,
monitoring of early response to NAC using MIBI has been limited to planar
imaging only (scintimammography and breast-specific gamma imaging [BSGI]) and
in relatively small series of patients. Improvements in Single-Photon Emission
Computed Tomography (SPECT) software modules, incorporated in the last
generation of SPECT/CT devices as currently available at LUMC and Alrijne
hospital, enable us to quantitatively study MIBI uptake and retention in
tumours including other metabolic parameters and as thus define their role in
therapy monitoring.
Study objective
Primary objective: To assess accuracy and reproducibility of a new and
innovative quantitative SPECT image reconstruction technique (QMetrix®) in
locally advanced breast cancer.
Secondary objectives: To evaluate:
a) Hanging breast acquisition mode using SPECT/CT in relation to the following
aspects: timing, patient comfort, image quality, (semi)quantitative parameters.
b) The feasibility of intratumoural heterogeneity analysis using visual scoring
and quantitative textural lesion assessment.
c) To explore if the (semi)quantitative parameters correlate with the
pathologic response to NAC and/or other systemic treatments.
Study design
Single centre prospective feasibility study
Additional SPECT-CT acquisition in hanging breast mode before and after BSGI
(standard care), 5 min and 90 min after intravenous injection of
99mTc-sestamibi.
Study burden and risks
Participation in this study does not impose significant risks for patients or
staff. Each patient will receive two additional low dose-CT thorax scans in a
total time frame of two hours, which is associated with an additional radiation
exposure of 2 x 2.7 mSv = 5.4 mSv. This is within the normal range concerning
diagnostic procedures. No side effects or significant risks are expected.
The risk for radiation-induced cancer corresponds to risk category IIb
(according to national and European guidelines); This study complies with the
requirements associated with this risk category because it is aimed at
developing diagnostic techniques for early identification of non-responders in
order to timely adjust the therapeutic regimen with the final aim to improve
the prognosis of this patient group.
Albinusdreef 2 1
Leiden 2333ZA
NL
Albinusdreef 2 1
Leiden 2333ZA
NL
Listed location countries
Age
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
* Pregnancy
* Proven BC with index lesion < 2 cm
* Prior breast surgery, chemotherapy, or radiation therapy
* Clinical or radiological evidence of metastatic lymph nodes (cN+)
* Clinical or radiological evidence of distant metastases (cM+)
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| CCMO | NL60403.058.17 |