Clinical trial · Observational
Prediction of Clinical Response and Outcome in Uterine Cervix Cancer
Predicting Clinical Response and Outcome After Definitive Irradiation With MRI-Guided Adaptive Brachytherapy in Uterine Cervix Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Observational study based on the routine clinical treatment and diagnostic course, to correlate imaging features with outcome objectives. Outcome will evaluated as clinical response to the standard treatment and as recurrence and survival in the follow up. The study hypothesis is that data extracted form FDG-PETCT used in the routine clinical practice can predict outcomes following standard treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervix Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change of SUV-related tumor characteristics predicting recurrence
- timeFrame
- Changes of parameters will be calculated on the pretreatment scan, than in average 2.5 months after the last radiotherapy session, than at least each 6 month for the first 2 years, eventually shortening the interval if clinically needed
- description
- * Standard Uptake Value Max (SUV- defined as the ratio of tissue radioactivity concentration (e.g. in MBq/kg=kBq/g) at time t, c(t), and the injected activity ( in MBq) at the time of injection (t=0) divided by the body weight in kg), * Metabolic Volume (MV) calculated in cc:volume of the evaluable metabolic activity on the PET scan calculated in a specific Region of Interest (ROI) semiautomatically delineated on the primary tumor in the uterine Cervix
Secondary outcomes (3)
- measure
- Change of SUV-related tumor characteristics predicting clinical overall response
- timeFrame
- Changes of parameters will be calculated on the pretreatment scan, and in average 2.5 months after the last radiotherapy session.
- description
- * Standard Uptake Value Max (SUV- defined as the ratio of tissue radioactivity concentration (e.g. in MBq/kg=kBq/g) at time t, c(t), and the injected activity ( in MBq) at the time of injection (t=0) divided by the body weight in kg), * Ratio of Pre/Post treatment SUV MAX,
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed cervix carcinoma (all subtypes) * Tumor Stages FIGO IB - IVA * Scheduled for primary curative radiotherapy (either or not combined with chemotherapy or hyperthermia) * pre treatment FDG PETCT * The patient is willing and capable to comply with study procedures * 18 years or older * Written informed consent to the treatment Exclusion Criteria: * Recent (\< 3 months) myocardial infarction * Uncontrolled infectious disease * Pregnant or breast feeding and/or not willing to take adequate contraceptive measures during the study * Previous surgery to the Cervix * Previous radiation to the Cervix
References
Publications (0)
Data not yet available