Application of Integrated MR-PET in Patients With Gynecologic Cancers

NCT02292615 | Unknown

• 1 other identifier: 201402075MIND
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

MR-PET Imaging

Outcome Measures

Primary Outcomes (1)

• The imaging biomarkers determined by MR-PET

  3 months

Study Arms (3)

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

Interventions

Medical Imaging OTHER

cervical cancer; endometrial cancer; ovarian cancer

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Tiffany Ting-Fang Shih, MD

  Department of Medical Imaging, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany Ting-Fang Shih, MD

CONTACT

886223123456; ttfshih@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: November 17, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2014
• Last Updated: November 17, 2014

Record last verified: 2014-11

Locations

TW (1)