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Para-Aortic Lymph Nodal Staging & Evaluation of Treatment Outcome by 18F FDG-PET in Advanced Cancer Cervix

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr Umesh Mahantshetty, Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00193752
First received: September 13, 2005
Last updated: March 26, 2017
Last verified: March 2017
  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
Cancer of Cervix Other: PET IMAGING

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 Cervical Cancer

Resource links provided by NLM:


Further study details as provided by Dr Umesh Mahantshetty, Tata Memorial Hospital:

Primary Outcome Measures:
  • PET Scan for Para-Aortic Staging in Carcinoma Cervix [ Time Frame: 5 years ]
  • Clinical (FIGO), MRI, and PET - Abdomen and Pelvis Correlation [ Time Frame: 5 years ]
  • Volumetric Correlation of Local Disease by PET and MRI [ Time Frame: 5 years ]
  • Radiotherapy Response Evaluation and Post therapy Surveillance by serial PET Scans [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 5 years ]

Estimated Enrollment: 100
Study Start Date: September 2005
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
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   (Adult)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193752

Locations
India
Tata Memorial Hospital
Mumbai, Maharastra, India, 400 012
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Shyamkishore J Shrivastava, MD, DNB (RT) Professor & Head, Radiation Oncology, Tata Memorial Hospital
  More Information

Responsible Party: Dr Umesh Mahantshetty, Professor, Radiation Oncology, 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: March 26, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Dr Umesh Mahantshetty, 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

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 June 23, 2017