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Para-Aortic Lymph Nodal Staging and Evaluation of Treatment Outcome by 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in Advanced Cancer Cervix

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Tata Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00193752
First received: September 13, 2005
Last updated: July 14, 2008
Last verified: July 2008
History of Changes
  Purpose

18F-fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Imaging has been extensively used in the evaluation of various malignancies and is rapidly being recognized as a mandatory investigations. 18F-fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Imaging has also been tried in cervical cancers with excellent results for detection of both pelvic and extra-pelvic disease in terms of sensitivity and specificity. Till date, PET Imaging has been reported to have highest sensitivity and specificity for detection of disease and treatment failures compared to other non-invasive investigations available. Treatment decisions (Localized RT Vs Extended RT) will be according to the results of PET Scans. The treatment response, outcome and follow-up will be labelled according to the PET Scan results and will be directed for treatment accordingly.


Condition Intervention Phase
Cancer of Cervix
 Other: PET IMAGING
 Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Para-Aortic Lymph Nodal Staging and Evaluation of Treatment Outcome by 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in Advanced Cancer Cervix

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • PET Scan for Para-Aortic Staging in Carcinoma Cervix [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Clinical (FIGO), MRI, and PET - Abdomen and Pelvis Correlation [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Volumetric Correlation of Local Disease by PET and MRI [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Radiotherapy Response Evaluation and Post therapy Surveillance by serial PET Scans [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2005
Estimated Study Completion Date: September 2010
Intervention Details:
    Other: PET IMAGING
    PET imaging in cervical cancers to predict, prognosticate outcome in cervical cancers
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with hisotologically proven cervical cancers with FIGO II-IIIB eligible for the study will be invited for the study

Criteria

Inclusion Criteria:

  • Histologically proven squamous carcinoma or adenocarcinoma of cervix
  • Performance index WHO grade 0 or 1
  • Patients below 65 years of age
  • FIGO Stage IIB / IIIB
  • Normal ECG and Cardiovascular system
  • Normal hematological parameters
  • Normal renal and liver function tests
  • Normal Blood Sugar levels / Controlled Diabetes

Exclusion Criteria:

  • Co-morbid conditions like medical renal disease
  • Past History of Phobia for MRI Examination
  • Medical or Psychological condition that would preclude Investigations / Treatment
  • H/o Previous treatment / Pregnancy
  • Patient unreliable for treatment completion and follow-up Investigations.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193752

Contacts
Contact: Shyamkishore J Shrivastava, MD, DNB(RT) +91-22-2417 7163 sshyam@mtnl.net.in
Contact: Umesh M Mahantshetty, MD, DNB (RT) +91-22-2417 7168 drumeshm@yahoo.com

Locations
India
Tata Memorial Hospital Recruiting
Mumbai, Maharastra, India, 400 012
Contact: Shyamkishore J Shrivastava, MD, DNB (RT)     +91-22-2417 7163     sshyam@mtnl.net.in    
Contact: Umesh M Mahantshetty, MD, DNB (RT)     +91-22-2417 7168     drumeshm@yahoo.com    
Principal Investigator: Shyamkishore J Shrivastava, MD, DNB (RT)            
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Shyamkishore J Shrivastava, MD, DNB (RT) Professor & Head, Radiation Oncology, Tata Memorial Hospital
  More Information

No publications provided

Responsible Party: Dr SK Shrivastava, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT00193752     History of Changes
Other Study ID Numbers: TMH/205/2004/Cx_PET STUDY
Study First Received: September 13, 2005
Last Updated: July 14, 2008
Health Authority: India: Department of Atomic Energy

Keywords provided by Tata Memorial Hospital:
FDG-PET Imaging
Cervical Cancer
Post-treatment evaluation
Para-aortic Nodal Staging
 Extended field Radiation
Extended field IMRT
Cancer of the Cervix
Cervix Cancer

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 19, 2013