SPectroscopic Assessment of Chemotherapy Efficacy in breast cancer patients

SPectroscopic Assessment of Chemotherapy Efficacy in breast cancer patients - SPACE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47637

Enrollment

Registered

2014-10-16

Start date

2014-11-28

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

breast cancer breast neoplasm

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Secondary study parameters as measured with (DCE-MRI, DWI, CEST-MRI) of the tumor prior to chemotherapy and after the first cycle of chemotherapy: - DCE-MRI: Ktrans and kep values; - DWI: ADC values; - CEST-MRI: magnetisation transfer ratio (MTR) values.	—

Countries

Netherlands

Outcome results