ano-MRI on 7 Tesla: A technical validation study in rectal and breast cancer

Completed

• Conditions: lymph node metastases; 10027476

• Registration Number: NL-OMON43904
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

General criteria:
- Age > 18 years;Inclusion criteria rectal cancer patients:
- Patients with recently histologically proven rectal cancer, who are either:
o Planned to undergo a total mesorectal excision without neo-adjuvant radiotherapy.
Or
o Planned to undergo a short radiotherapy program (5x5 Gy) followed by a total mesorectal excision in the next week.;Inclusion criteria breast cancer patients:
- Patients with recently diagnosed breast cancer who: ;o Have proven axillary lymph node involvement based on cytological analysis of ultrasound guided fine needle aspiration of suspicious axillary lymph nodes and receive no neoadjuvant therapy.
OR
o have an estimated invasive primary tumor size of 2-5 cm (cT2) and are planned for surgery with sentinel node procedure, but will receive no neo-adjuvant therapy and are not of low grade based on histopathological analysis of the core needle biopsy specimen.
OR
o will undergo an axillary lymph node dissection without prior sentinel node procedure and will receive no neo-adjuvant therapy.

Exclusion Criteria

General:
- Abdominal circumference > 120 cm
- Pregnancy
- Karnofsky score <= 70
- Contraindications for 7T MRI
- Contraindications for ferumoxtran;Specific for patients with rectum carcinoma:
- Inflammatory bowel disease
- Prior oncological related abdominal and/or pelvic surgery or radiotherapy;Specific for patients with breast carcinoma:
- Prior radiotherapy or surgery to axillae

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sensitivity and specificity of 7 Tesla nano-MRI in rectal and breast cancer</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Initial comparison of the 7 Tesla nano-MRI results with 3 Tesla nano-MRI. </p><br>