Validation of (semi)quantitative metabolic SPECT/CT for therapy monitoring in Locally Advanced Breast Cancer: A Feasibility Study
Completed
- Conditions
- Locally advanced breastcancerLocally advanced Mamma carcinoma10006291
- Registration Number
- NL-OMON47441
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 19
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+)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Endpoint: Validation of 99mTc-sestamibi-based (semi)quantitative metabolic<br /><br>SPECT/CT parameters like standardized uptake value (SUVSPECT), metabolic tumour<br /><br>volume (MTVSPECT), total lesion mitochondrial uptake (TLMU), lesion wash-out<br /><br>(LWO) and tumour to background ratio (T/B), using a quantitative SPECT image<br /><br>reconstruction technique (QMetrix®), for therapy monitoring purposes in<br /><br>patients with LABC<br /><br><br /><br>Outcome measures:<br /><br>- Percentage of BC patients in whom the above mentioned parameters can be<br /><br>technically measured using Q.Metrix® quantitative image reconstruction and<br /><br>SPECT/CT in hanging breast mode;<br /><br>- Actual measured (semi)quantitative data concerning the above mentioned<br /><br>metabolic tumour parameters;<br /><br>- Reproducibility analysis of these (semi)quantitative findings.</p><br>
- Secondary Outcome Measures
Name Time Method