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

This study is currently recruiting participants.

Verified by Tata Memorial Hospital, July 2008

First Received: September 13, 2005 Last Updated: July 14, 2008 History of Changes

Sponsored by:	Tata Memorial Hospital
Information provided by:	Tata Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00193752

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 II

MedlinePlus related topics: Cancer Cervical Cancer Nuclear Scans Radiation Therapy

Drug Information available for: Fluorodeoxyglucose F18

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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

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:

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, Maharastra
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:	Tata Memorial Hospital ( Dr SK Shrivastava )
Study ID Numbers:	TMH/205/2004/Cx_PET STUDY
Study First Received:	September 13, 2005
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00193752 History of Changes
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
Cervical Cancer
Cancer of the Cervix
Cervix Cancer

Study placed in the following topic categories:

Genital Diseases, Female
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Genital Neoplasms, Female

Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms

Additional relevant MeSH terms:

Genital Diseases, Female
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Neoplasms
Neoplasms by Site

Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009