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Validation of ultrahigh field (7 Tesla) MRI with whole mount pathology in rectal cancer

Validation of ultrahigh field (7 Tesla) MRI with whole mount pathology in rectal cancer - 7MaRC

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48569
Enrollment
10
Registered
2017-08-28
Start date
2018-03-27
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

rectal cancer

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Informed consent for PLCRC; * Informed consent for the use of clinical data * Informed consent for future studies within PLCRC; * Eligible for neoadjuvant radiotherapy; * Eligible for rectal surgery by Total Mesorectal Excision (either Low Anterior Resection, Abdominoperineal Resection or Hartmann resection).

Exclusion criteria

Exclusion criteria: * Patients with distant metastasis requiring surgery between chemoradiation and rectal surgery; * MRI contraindications according to the MR safety protocol of the imaging division of the UMC Utrecht.

Design outcomes

Primary

MeasureTime frame
The accuracy of 7 Tesla MRI in determining the residual tumour volume, location, and extension after neoadjuvant radiotherapy. Location is determined by comparison of the center of the tumour on 7T images and in whole mount pathology. The tumour extension is defined as the distance between the outline of the tumour in pathology and the tumour outline on imaging.

Secondary

MeasureTime frame
Define the most optimal 7T sequences in determining tumour volume, validated with pathology;. If available, a comparison of tumour volume as determined on 7T and 3T images will be made.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)