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CompletedNCT00907140Updated Jan 20, 2017

Fludeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) Cervical Heterogenity Imaging Study

An interventional study of Positron Emission Tomography in Cervical Cancer, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2017-01-20.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
Female
01

Study summary

Rationale: Diagnostic procedures, such as positron emission tomography (PET) using fluorodeoxyglucose (FDG), may help determine response to standard cancer therapy in patients with cervical cancer

The purpose of this study is to evaluate the change in cervical tumor heterogenity as measured by FDG-PET/CT imaging.

02

Conditions studied

  • Cervical Cancer

Keywords

  • Cervical Cancer
  • Positron Emission Tomography
  • Fluorodeoxyglucose
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 25 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Biopsy-proven cervical cancer. (FIGO stage-Ib2-IVa)
  2. Age ≥ 18
  3. Able to receive chemoradiation therapy with Cisplatin.
  4. Non-pregnant status in women of childbearing potential.
  5. No other active cancer at the time of diagnosis of cervical cancer Patients cannot have received treatment for any malignancy, with the exception of non-melanoma skin cancer, in the past 5 years.
  6. Patients with distant metastatic disease are eligible provided the estimated survival of the patient is at least 1 year.
  7. Scheduled to undergo or have already undergone FDG-PET/CT imaging for clinical staging of cervical cancer at Barnes-Jewish Hospital Clinical PET Facility on a Biograph 40 PET/CT scanner
  8. Able to give informed consent

Exclusion criteria

Exclusion Criteria:

  1. Age \< 18
  2. Patients with a known active malignancy other than cervical carcinoma.
  3. Pregnant and breastfeeding patients.
  4. Subjects whose tumors are not FDG avid on baseline standard of care FDG-PET/CT imaging
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Other
    Chemoradiation therapy

    Procedure: Positron Emission Tomography

Interventions

  • ProcedurePositron Emission Tomography

    FDG PET/CT imaging is performed at baseline, after 2 and 4 weeks of radiation therapy and approximately 3 months after chemoradiation is completed

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What researchers measure

Primary outcomes

  1. The overall goal of this pilot study is to evaluate the change in cervical tumor FDG heterogeneity and SUVmax during chemoradiation.

    Time frame: FDG PET/CT imaging is performed at: Baseline, 2 & 4 weeks of therapy, and 3 months after completing therapy

Secondary outcomes

  1. To correlate changed in FDG heterogeneity and SUVmax with response to therapy.

    Time frame: 5 years

07

Study locations

1 site
  • Washington University at St. Louis
    Saint Louis, Missouri 63110, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00907140
Lead sponsor
Washington University School of Medicine
Responsible party
Farrokh Dehdashti (Co-Principal Investigator, Washington University School of Medicine) — Principal investigator
First posted
May 22, 2009
Start date
Aug 2008
Primary completion
Nov 2010
Completion
Dec 2016
Last update
Jan 20, 2017

Study contacts

Perry W Grigsby, M.D.
principal investigator · Washington University at St. Louis

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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