Application of Integrated MR-PET in Patients With Gynecologic Cancers

NCT ID: NCT02292615

Last Updated: 2014-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Brief Summary

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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

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Conditions

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MR-PET Imaging

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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cervical cancer

Group 1: Patients with newly diagnosed gynecologic cancers (including cervical, endometrial, and ovarian cancers).

Medical Imaging

Intervention Type OTHER

endometrial cancer

Group 2: Patients with suspicious recurrent gynecologic cancers (including cervical, endometrial, and ovarian cancers).

Medical Imaging

Intervention Type OTHER

ovarian cancer

Group 3: Patients with ovarian cancer who had debulking surgery and are going to receive adjuvant chemotherapy.

Medical Imaging

Intervention Type OTHER

Interventions

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Medical Imaging

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tiffany Ting-Fang Shih, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Imaging, National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Tiffany Ting-Fang Shih, MD

Role: CONTACT

886223123456 ext. 65568

Facility Contacts

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Shih Tiffany Ting-Fang, MD

Role: primary

886223123456 ext. 65568

Other Identifiers

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201402075MIND

Identifier Type: -

Identifier Source: org_study_id