SPectroscopic Assessment of Chemotherapy Efficacy in breast cancer patients

Completed

• Conditions: breast cancer; breast neoplasm; 10006291; 10006232

• Registration Number: NL-OMON47637
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 76

Inclusion Criteria

- 18 years or older;
- Female breast cancer patients selected for neoadjuvant chemotherapy;
- Stage Ic (max. 3 cm retromammilair, min. B cup size), II and III tumors.

Exclusion Criteria

- Any prior surgery or radiotherapy for malignancy to the ipsilateral breast;
- Prior chemotherapy within 1 year;
- Karnofsky score of 70 or less;
- Pregnant or lactating women;
- Contra-indications to MRI scanning according to hospitals 7T MRI screening
guideline of the UMC Utrecht or the AMC;
- Contraindications to administration of gadolinium-based contrast agent,
including: prior allergic reaction to a gadolinium-based contrast agent and/or
renal failure (defined as GFR < 30mL/min/1,73m2).

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Phosphomonoester (PME) / Phosphodiester (PDE) or alternatively PME / inorganic<br /><br>phospor (Pi) signal ratios, prior to, and after the first cycle of chemotherapy<br /><br>as obtained from 31P-MRS as a function of pathologic non-response and positive<br /><br>lymph nodes.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters as measured with (DCE-MRI, DWI, CEST-MRI) of the<br /><br>tumor prior to chemotherapy and after the first cycle of chemotherapy:<br /><br>- DCE-MRI: Ktrans and kep values;<br /><br>- DWI: ADC values;<br /><br>- CEST-MRI: magnetisation transfer ratio (MTR) values.</p><br>