Clinical trial · Interventional
Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy
NCT02040155CI-TRIAL-00027378completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is an observational study. The purpose is to determine the feasibility of using a novel nano-scintillator fiber-optic dosimeter (nanoFOD) for the real time dosimetric monitoring of brachytherapy treatment. Women with gynecologic cancers treated with brachytherapy as part of their standard therapeutic regimen will represent the study population.
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 |
|---|---|---|---|
| Cancer of the Cervix, Cancer of the Endometrium | Malignant Cervical Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Novel nano-scintillator fiber-optic dosimeter (nanoFOD) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Real time dosimetric monitoring of brachytherapy.
- interventionNames
- Device: Novel nano-scintillator fiber-optic dosimeter (nanoFOD)
Primary outcomes (1)
- measure
- Measure dosimetric accuracy of the device with reference to a commercially available dosimeter.
- timeFrame
- 24 months
- description
- This will only be possible in a subset of women whose implant geometry will result in a radially symmetric dose cloud (i.e. vaginal cylinder cases) so that both the nanoFOD and the reference dosimeter may be placed in a position expected to have the same, or closely similar dose.
Secondary outcomes (1)
- measure
- Confirm feasibility of clinical application of the nanoFOD for dosimetric monitoring of brachytherapy with complex geometry implants.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented neoplasm of the female genital tract. * Planned brachytherapy as part of standard of care treatment. * Age \> 18 years * Able to provide and execute informed consent Exclusion Criteria: * Any clinical scenario in which the nanoFOD placement or reading would compromise the treatment efficacy, or endanger the patient in any way.
References
Publications (0)
Data not yet available
No reference posted for this study.