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SUV Max as Predictor of Outcome in Cervical Cancer

This study has been completed.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01262144
First received: November 23, 2010
Last updated: December 15, 2010
Last verified: November 2010
History of Changes
  Purpose

Cervical Cancer is staged clinically, not surgically. Patients in whom an extensive disease is identified are not usually eligible for surgery. PET-CT is used to support staging. However, some patients received surgery after staging and subsequently require radio/chemotherapy due to findings on operation.

This study will attempt to find a correlation between SUV-Max on PET-CT and subsequent outcomes i.e. need for adjuvant therapy.


Condition Intervention
Cervical Cancer
 Radiation: Radiotherapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Study to Evaluate the Value of SUV-Max in PET-FDG in Predicting Outcome of Surgery Vis a Vis Need for Radiotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Administration of adjuvant therapy [ Time Frame: immediately following surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: surgery - present day ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2010
Groups/Cohorts Assigned Interventions
Case group Radiation: Radiotherapy
Radiotherapy for cervical cancer

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Females age 18-80, diagnosed with cervical cancer

Criteria

Inclusion Criteria:

  • having stating PET-CT stored on site
  • treated with surgery

Exclusion Criteria:

  • not eligible for surgery based on PET-CT, clinical stage
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262144

Locations
Israel
Rambam Medical Center
City, Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Amnon Amit, MD Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Dr. Amit Amnon, director, gynecologic oncology unit, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01262144     History of Changes
Other Study ID Numbers: 421CTIL
Study First Received: November 23, 2010
Last Updated: December 15, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
Cervical Cancer
PET CT
SUV Max

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 16, 2013