Application of Integrated MR-PET in Patients With Gynecologic Cancers

• Conditions: MR-PET Imaging
• Interventions: Other: Medical Imaging

• Registration Number: NCT02292615
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

In this prospective cohort study, patients with newly diagnosed gynecologic cancers (including cervical, endometrial, and ovarian cancers) and patients with suspicious recurrent gynecologic cancers will be enrolled. The study period is two years and the estimated patient number is about 220. Patients will undergo image study before and after treatment. The diagnostic accuracy of MR-PET in cancer staging and the potential image biomarkers to monitor treatment response and predict treatment outcome will be investigated.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2014-04
• Status Verified: 2014-11
• Study First Submitted: 2014-11-12
• Study First Submitted QC: 2014-11-12
• Last Update Submitted: 2014-11-12
• Study First Posted: 2014-11-17
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

1. Group 1: Patients with newly diagnosed gynecologic cancers (including cervical, endometrial, and ovarian cancers).
2. Group 2: Patients with suspicious recurrent gynecologic cancers (including cervical, endometrial, and ovarian cancers).
3. Group 3: Patients with ovarian cancer who had debulking surgery and are going to receive adjuvant chemotherapy.

Exclusion Criteria

1. Age <20 or >90 years old
2. Contraindication for MRI:
3. Contraindication for MR contrast medium (Cre > 2.0)
4. History of other malignancy
5. Prior arthroplasty of hip or pelvic bone surgery with metallic fixation (may cause artifacts on MRI)
6. Pregnant or lactating women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cervical cancer	Medical Imaging	Group 1: Patients with newly diagnosed gynecologic cancers (including cervical, endometrial, and ovarian cancers).
ovarian cancer	Medical Imaging	Group 3: Patients with ovarian cancer who had debulking surgery and are going to receive adjuvant chemotherapy.
endometrial cancer	Medical Imaging	Group 2: Patients with suspicious recurrent gynecologic cancers (including cervical, endometrial, and ovarian cancers).

Primary Outcome Measures

Name	Time	Method
The imaging biomarkers determined by MR-PET	3 months

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan