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The PLCRC substudy Ultra high field 7.0 Tesla MR Spectroscopy to monitor capecitabine metabolism in liver metastases - a proof of concept study

The PLCRC substudy Ultra high field 7.0 Tesla MR Spectroscopy to monitor capecitabine metabolism in liver metastases - a proof of concept study - The PLCRC - SPECTRE study

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43450
Enrollment
26
Registered
2016-03-10
Start date
Unknown
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

bowel cancer Colorectal cancer

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -18 years or older. -Patients with liver metastases measurable according to RECIST in metastatic colorectal cancer. -Patients that are planned to start with capecitabine and bevacizumab treatment as determined according to Dutch guidelines. -Informed consent for longitudinal data collection according to the PLCRC study protocol.

Exclusion criteria

Exclusion criteria: • Patients receiving triple chemotherapy for mCRC. • Patients that received or currently receive any other kind of systemic therapy for cancer. • Patients that received any prior radiotherapy or surgery in the liver. • Patients with a dihydropyrimindine dehydrogenase (DPD) deficiency (heterozygous or homozygous). • Contra-indications to MRI scanning according to hospitals 7T MRI screening guideline of the UMCU. • Patients with severe liver dysfunction. • Patients with a life expectancy of

Design outcomes

Primary

MeasureTime frame
7T MRS characteristics on (changes in) concentration of capecitabine and metabolites measured in liver metastasis during MRS examinations obtained at discretized time point(s).

Secondary

MeasureTime frame
Secondary endpoints include response measurements (complete response, partial response, stable disease and progressive disease) according to RECIST and detailed information on perfusion, diffusion and acidity as determined by functional MRI.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)