Clinical trial · Observational
Functional Imaging of Tumor and Normal Tissue
The Use of Functional Imaging to Quantify Tumor and Normal Tissue Physiology in Patients With Locally Advanced Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding ceased
Summary
Brief summary (as posted)
Dynamic contrast-enhanced (DCE) - magnetic resonance imaging (MRI), diffusion-weighted (DW)-MRI, and fludeoxyglucose - positron emission tomography - computed tomography (FDG-PET-CT) are three modalities that generate non-invasive, functional images of tumors and normal tissues based on physiologic properties including perfusion, vascular permeability and glucose metabolism. Demonstrating that these parameters are associated with clinical outcome, either efficacy or toxicity, could enhance the ability to select patients for different treatment strategies and improve the therapeutic ratio.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI and PET imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Functional Imaging
- description
- Functional imaging with MRI and PET
- interventionNames
- Procedure: MRI and PET imaging
Primary outcomes (1)
- measure
- Permeability, perfusion, diffusion and glucose metabolism
- timeFrame
- At end of 1 week of radiation therapy
Secondary outcomes (1)
- measure
- Relationships between baseline and treatment induced changes in vascular permeability, perfusion, interstitial space, glucose metabolism, and saliva production to identify prognostic and predictive parameter(s) for treatment
- timeFrame
- 1 year of completing radiation therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented squamous cell carcinoma of the head and neck (AJCC stages II-IV, M0) * Eligible anatomic sites: Oral cavity, oropharynx, hypopharynx, supraglottic and glottic larynx, or nasopharynx * Curative intent concurrent chemoradiation * Age \> 18 years * Karnofsky Performance Status \> 60 * Able to undergo MRI with contrast (gadolinium) and/or FDG PET scan Exclusion Criteria: * Diabetes other than diet controlled * MRI Absolute Contraindications including: * Glomerular filtration rate \< 60 ml/min * Weight \< 350 lb or current device limitations * Metallic foreign bodies in the eye * Cardiac pacemakers * Clips in the central nervous system (ferromagnetic haemostatic) * Automatic internal cardiac defibrillators * Cochlear implants * Shrapnel in vital locations * Pregnant (positive pregnancy test) or lactating
References
Publications (2)
- BACKGROUNDBrizel DM, Rosner GL, Prosnitz LR, Dewhirst MW. Patterns and variability of tumor oxygenation in human soft tissue sarcomas, cervical carcinomas, and lymph node metastases. Int J Radiat Oncol Biol Phys. 1995 Jul 15;32(4):1121-5. doi: 10.1016/0360-3016(95)00106-9. PMID 7607933
- BACKGROUNDKirkpatrick JP, Cardenas-Navia LI, Dewhirst MW. Predicting the effect of temporal variations in PO2 on tumor radiosensitivity. Int J Radiat Oncol Biol Phys. 2004 Jul 1;59(3):822-33. doi: 10.1016/j.ijrobp.2004.02.015. PMID 15183486