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van CCT (UK)

van CCT (UK)

Saving breast cancer patients from ineffective treatment.

- candidate number21090
- NTR NumberNTR4980
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-nov-2014
- Secondary IDsdr. ir. Jannie Wijnen 
- Public TitleSaving breast cancer patients from ineffective treatment.
- Scientific TitleSPACE: SPectroscopic Assessment of Chemotherapy Efficacy
- hypothesisIn vivo 31P MRS at ultra high field before and after the first cycle of neoadjuvant chemotherapy can predict the response to neoadjuvant chemotherapy in breast cancer patients.
- Healt Condition(s) or Problem(s) studiedBreast cancer, Neoadjuvant chemotherapy, MRI, 31P Magnetic Resonance Spectroscopy
- 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• 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 28-okt-2014
- planned closingdate28-okt-2018
- Target number of participants126
- Interventionsnone
- Primary outcomeMain 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 outcomeSecondary 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
- TimepointsMRS/MRI: before first cycle of NAC, 2 weeks after first cycle of NAC. Pathological response: after 6 cycles of NAC at surgery.
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Alpe d’HuZes Foundation, KWF Kankerbestrijding
- Publications
- Brief summaryChemotherapy before surgery (neoadjuvant chemotherapy) is used in patients with aggressive breast cancer to shrink the tumor and to prevent the chance of distant metastases. Unfortunately, the effect of neoadjuvant chemotherapy can only be assessed in a late phase of the therapy. Therefore, in case of an ineffective therapy, patients already suffered from the side effects of chemotherapy without any benefit. Currently, no good non-invasive method capable of assessing the efficacy of chemotherapy before the surgery is available. Although studies using Magnetic Resonance Imaging (MRI) detected changes in vascularity and cell density, no threshold value was established that could predict response to chemotherapy early after the start of treatment. The reason for this could be that parameters such as vascularity and cell density do not reflect tumor metabolism, which may be a better indicator of tumor aggressiveness and will be influenced by chemotherapy in an earlier stage than that changes in vascularity or cell density present. Preclinical studies indicate that the phospholipid membrane metabolism –responsible for cell membrane synthesis- is changed in cancer. We have developed a unique setup, consisting of a high field MRI scanner (7 Tesla) and dedicated receiver coils, capable of assessing this aberrant metabolism in a non-invasive way directly in the patients by using 31P-Magnetic Resonance Spectroscopy (31P-MRS). Purpose: To determine by 31P MRS early on in the course of neo-adjuvant chemotherapy whether or not a breast cancer patient responds to the chemotherapy. This enables the identification of patients that benefit from neo-adjuvant chemotherapy and prevent patients that do not respond to neo-adjuvant chemotherapy from having ineffective chemotherapy
- Main changes (audit trail)
- RECORD30-nov-2014 - 13-mrt-2015

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