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Clinical Trials/NCT02292615
NCT02292615UnknownNot Applicable

Application of Integrated MR-PET in Patients With Gynecologic Cancers

National Taiwan University Hospital1 site in 1 country220 target enrollmentStarted: April 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
220
Locations
1
Primary Endpoint
The imaging biomarkers determined by MR-PET

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 90 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

The imaging biomarkers determined by MR-PET

Time Frame: 3 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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