Application of Integrated MR-PET in Patients With Gynecologic Cancers

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.

Study Overview

• Status: Unknown
• Conditions: MR-PET Imaging
• Intervention / Treatment: Other: Medical Imaging

• Study Type: Observational
• Enrollment (Anticipated): 220

Contacts and Locations

• Study Contact: Name: Tiffany Ting-Fang Shih, MD; Phone Number: 65568 886223123456; Email: ttfshih@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Shih Tiffany Ting-Fang, MD; Phone Number: 65568 886223123456; Email: ttfshih@ntu.edu.tw
    • Principal Investigator: Shih Tiffany Ting-Fang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The imaging biomarkers determined by MR-PET	3 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Tiffany Ting-Fang Shih, MD, Department of Medical Imaging, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: November 12, 2014
• First Submitted That Met QC Criteria: November 12, 2014
• First Posted (ESTIMATE): November 17, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): November 17, 2014
• Last Update Submitted That Met QC Criteria: November 12, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 201402075MIND