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Saving breast cancer patients from ineffective treatment.

SPACE: SPectroscopic Assessment of Chemotherapy Efficacy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28036
Enrollment
126
Registered
2014-11-30
Start date
2014-10-28
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

breast cancer - borsht kanker neoadjuvant chemotherapy - neoadjuvante chemotherapie response to therapy - response op therapie 31P Magnetic Resonance Spectroscopy - fosfor Magnetische resonantie spectroscopie MRI- MRI

Interventions

none

Sponsors

University Medical Centre Utrecht Amsterdam Medical Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • age of 18 years or older • female breast cancer patients (HER2 negative breast cancer, stage II or III) • selected for neo-adjuvant chemotherapy

Exclusion criteria

Exclusion criteria: • any prior surgery or radiotherapy to the ipsilateral breast • Karnofsky score <= 70, • Pregnant or lactating women • Contra-indications to MRI scanning according to hospitals 7T MRI screening guideline of the UMCU.

Design outcomes

Primary

MeasureTime frame
Main study parameters are the signal ratios of ME/PDE or alternatively PME/Pi as obtained with 31P-MRS that should discriminate between responders and non-responders. Non responders show unchanged or even higher PME/PDE and PME/Pi ratios after the first cycle of chemotherapy whereas (partial) responders show a significant decrease in these ratios.

Secondary

MeasureTime 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

Contacts

Public ContactJ.P. Wijnen

University Medical Centre Utrecht, Room number Q 04 4311

jwijnen@umcutrecht.nl+31 (0)88 75 51353, +31 (0)30-2581098

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)