Feasibility of ultra high field 7.0 Tesla MR Spectroscopy for monitoring neo-adjuvant therapy efficacy.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. What change in phospholipid metabolites can be detected with 7T MRS during
neo-adjuvant therapy in breast cancer?
2. How strong does the change in phospholipid metabolism correlate to the
efficacy of therapy as obtained from histology and with tumor volume as
measured with standard contrast enhanced MRI.
Secondary outcome
How accurate can phospho-esters be determined with in vivo 7T MRS compared to
ex vivo analysis with LC-MS en HR MAS MRS?
Background summary
Every year over 12.000 Dutch women are diagnosed with invasive breast cancer.
This makes breast cancer the cancer type with the highest incidence in Dutch
women.
Chemo / endocrine / trastuzumab therapy after surgery as well as prior to
surgery (neo-adjuvant) is a possible treatment of these tumors. The Dutch
regulation for neo-adjuvant therapy states that prior to and halfway through
therapy a contrast enhanced MRI scan is made to assess possible tumor
progression (volume reduction or -growth), i.e. to assess whether the
neo-adjuvant therapy is effective in reducing tumor burden. In case of strong
tumour growth direct surgery can be indicated. Unfortunately, there is no
evidence in literature that volume reduction is a reliable measure of therapy
efficacy.
Recently ultra-high field 7.0 Tesla MRI has become clinically available. The
availability of ultra-high field 7T MRI offers new diagnostic possibilities:
due to the very high magnetic field strength of the scanner, images can be
acquired at a higher spatial resolution allowing smaller structural detail to
be depicted. For breast cancer this means not just the possibility of detection
of smaller lesions, but possibly also better morphologic classification of
detected lesions and better delineation of lesion extent. In addition, MR
Spectroscopy (MRS) at 7 Tesla offers the possibility to monitor therapy of
lesions by means of the detection of phospholipid metabolites that have shown
clinical potential as biomarkers for oncological disease in preclinical
studies.
Study objective
Feasibility of ultra high field 7.0 Tesla MR Spectroscopy for monitoring
neo-adjuvant therapy efficacy.
Study design
Prospective cohort study
Study burden and risks
The patient will have to fill out an 7T MRI contraindication form before
entering the 7T MRI area. The patient will undergo 3 MRI / MRS exams.
Two of the MRS scans can be scheduled just after the conventional MRI scan, for
this purpose performed at 7 Tesla (prior to and half way therapy). For the
last MRS scan at the end of the chemotherapy, just prior to surgery, the
patient has to come UMCU specifically for this study.
As far as is known there are no short- or long term risks involved in having an
MRS examination. Some patient will experience light flashes or tingling due to
the very high magnetic field of the 7 Tesla MRI. This will immediately
disappear when leaving the scanning area. Participants are not requested to
take any precautions or actions following to or prior to the MRS exam.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- Females
- breast cancer patients selected for neo-adjuvant therapy
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 the 7T screening list of the UMCU
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL36429.041.11 |
| OMON | NL-OMON25351 |