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NCT02317302
FDG Tumor Heterogeneity During Chemoradiation as a Predictor of Response in Patients With Cervical Cancer
Phase 1 trial testing FDG-PET/MR in Cervical Cancer in 48 participants. Terminated before completion.
2 June 2020
Quick facts
| Lead sponsor | Washington University School of Medicine |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 48 |
| Start date | 28 June 2011 |
| Primary completion | 2 June 2020 |
| Estimated completion | 2 June 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- FDG-PET/MR
- FDG-PET/CT
Conditions studied
- Cervical Cancer — all drugs for Cervical Cancer →
- Uterine Cervical Cancer — all drugs for Uterine Cervical Cancer →
- Uterine Cervical Neoplasms — all drugs for Uterine Cervical Neoplasms →
Sponsor
Washington University School of Medicine
Who can join
18 and older, female only, with Cervical Cancer or Uterine Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this study, 50 evaluable patients will undergo one FDG-PET study during their chemoradiation, in addition to the standard of care pretreatment and 3-month post-treatment clinical FDG-PET/CT or FDG-PET/MR scans. From all FDG-PET studies, tumor volume, SUVmax, FDGhetero, and texture maps will be obtained. Evaluating the changes in tumor SUVmax and heterogeneity during treatment will aid in better understanding the role of these biological parameters in inadequate response to chemoradiation. Other researchers, using MRI imaging, have evaluated changes in the cervical tumor volume during treatment. The investigators expect there will be variation in how cervical tumors shrink and change during chemoradiation and therefore we are going to use multiple measures in addition to tumor volume to evaluate cervical tumor metabolic heterogeneity. Being able to predict at diagnosis the patients who are at higher risk for persistent disease following chemoradiation would allow for future studies where these high risk patients could be specifically targeted with more aggressive therapy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
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Other Washington University School of Medicine trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02317302 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
- Last refreshed: 11 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02317302.
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