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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00193752
Date of registration: 13/09/2005
Primary sponsor: Tata Memorial Hospital
Public title: Para-Aortic Lymph Nodal Staging and Evaluation of Treatment Outcome by 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in Advanced Cancer Cervix
Scientific title: Para-Aortic Lymph Nodal Staging and Evaluation of Treatment Outcome by 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in Advanced Cancer Cervix
Date of first enrolment: September 2005
Target sample size: 100
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT00193752
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Countries of recruitment
India
Contacts
Name:   Shyamkishore J Shrivastava, MD, DNB (RT)
Address: 
Telephone: +91-22-2417 7163
Email: sshyam@mtnl.net.in
Affiliation: 
Name:   Shyamkishore J Shrivastava, MD, DNB(RT)
Address: 
Telephone: +91-22-2417 7163
Email: sshyam@mtnl.net.in
Affiliation: 
Name:   Shyamkishore J Shrivastava, MD, DNB (RT)
Address: 
Telephone:
Email:
Affiliation:  Professor & Head, Radiation Oncology, Tata Memorial Hospital
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Cancer of Cervix
Intervention(s)
Other: PET IMAGING
Primary Outcome(s)
Clinical (FIGO), MRI, and PET - Abdomen and Pelvis Correlation [Time Frame: 5 years]
PET Scan for Para-Aortic Staging in Carcinoma Cervix [Time Frame: 5 years]
Radiotherapy Response Evaluation and Post therapy Surveillance by serial PET Scans [Time Frame: 5 years]
Volumetric Correlation of Local Disease by PET and MRI [Time Frame: 5 years]
Secondary Outcome(s)
overall survival [Time Frame: 5 years]
Secondary ID(s)
TMH/205/2004/Cx_PET STUDY
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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