Clinical trial · Interventional
18F-FMISO PET Guided Dose Escalation in Nasopharyngeal Carcinoma - a Feasibility and Planning Study
NCT04995185CI-TRIAL-00077213completedN/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 study aims to investigate the use of 18F-FMISO PET in identifying hypoxic subvolume for dose escalation radiotherapy in nasopharyngeal cancer and thus improve local control without significant increase in toxicities.
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 |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| (18)F-fluoromisonidazole (FMISO) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET/CT imaging
- description
- Intravenous injection of 370MBq ± 10% (18)F-fluoromisonidazole
- interventionNames
- Radiation: (18)F-fluoromisonidazole (FMISO)
Primary outcomes (4)
- measure
- To investigate the dynamics of tumour hypoxia
- timeFrame
- From baseline and during 7 week long treatment regimen
- description
- A repeat 18F-FMISO-PET in week 3 of the 7 weeks long treatment regimen is planned. Fractionated radiotherapy is expected to induce reoxygenation within the tumor as iterative process by killing well oxygenated tumor cells with every fraction thereby reducing oxygen demand in the remaining tumor cells. Repetitive hypoxia imaging at week 3 allows for assessment of evolution of hypoxia during radiotherapy.
- measure
- To evaluate proportion of patients with contour-able hypoxic volume as well as the feasibility of generating dose-escalation radiotherapy plan with dosimetrically achieved parameters for target volume and organs-at-risk.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * T3-T4 disease with no evidence of distant metastasis. * Histological diagnosis of WHO Type II or III NPC * No evidence of distant metastases in staging work up (including lung, liver and bone imaging). * Planned for upfront radiotherapy and/or chemotherapy. * Cross sectional imaging of the primary and neck disease (MRI preferred) * Performance status of ECOG grade 0 or 1 * No prior tumour therapy * At least 21 years of age, of either sex. * Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential; * Adequate bone marrow, renal and hepatic function defined as follows: Bone marrow: WBC \> 3000 / mm3 (ANC \> 1500 / mm3 ) Platelets \> 100 000 / mm3. Hb \> 10 gm/dl Renal: serum creatinine within institutional normal range(or) lower than the lower limit of institutional normal range : calculated creatinine clearance \> 50 ml / min Hepatic: enzymes (SAP, SGOT) \< 2x normal: bilirubin \< 24 mol / l. Exclusion Criteria: * Allergic to 18F-fluoromisonidazole or Nitroimidazoles * Planned for neoadjuvant chemotherapy * Uncontrolled hypercalcaemia: calcium 2.7 mmol/L (10.8 mg/dL). * Other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator). * Have serious active infection. * Pregnant or lactating female subjects and subjects with reproductive potential not implementing adequate contraceptive measures
References
Publications (0)
Data not yet available
No reference posted for this study.