USPIO- enhanced High Field MRI for restaging lymph node status in rectal cancer: an explorative study

USPIO- enhanced High Field MRI for restaging lymph node status in rectal cancer: an explorative study - USPIO- enhanced High Field MRI for restaging rectal cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45911

Enrollment

Registered

2017-04-10

Start date

2017-09-06

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

lymph node metastases

Interventions

lymph node metastasis

lymphography

rectal cancer

USPIO

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: General criteria: - Age > 18 years;Specific Inclusion criteria:;- Patients with recently histologically proven rectal cancer, who are:;o Planned to undergo neoadjuvant radiotherapy 50.4 Gy with concomitant chemotherapy consisting of capecitabin 825-1000 mg/m2 and/or oxaliplatin 85 mg/m² .;and;o Planned to undergo a total mesorectal excision.

Exclusion criteria

Exclusion criteria: General exclusion criteria:;- Abdominal circumference > 120cm - Pregnancy;- Karnofsky score

Design outcomes

Secondary

Measure	Time frame
Comparing the sensitivity and specificity of 3T and 7T	—

Primary

Measure	Time frame
Sensitivity and specificity of 3T and 7T MRI scans with ferumoxtran-10 enhancement for lymph node metastasis detection after chemoradiotherapy in locally advanced rectal cancer patients. We will make a subdivision into small (	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)