Clinical trial · Interventional
Image-Guided Adaptive Radiotherapy for in Detecting Tumors During Treatment in Patients With Head and Neck Cancer
Image-Guided Adaptive Radiotherapy for Head And Neck Cancer: Patient Image Acquisition
NCT01843673CI-TRIAL-00022881completedN/AResults postedClinicalTrials.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 clinical trial studies image-guided adaptive radiotherapy in detecting tumors during treatment in patients with head and neck cancer. Image-guided adaptive radiotherapy uses high quality imaging technology to detect the tumor and normal organs during treatment. It is not yet known which imaging technique provides the best image for guidance during treatment with radiation therapy. Comparing results of imaging procedures done before, during, and after radiotherapy may help doctors plan the best 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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| computed tomography | Procedure | — | UNRESOLVED |
| cone-beam computed tomography | Procedure | — | UNRESOLVED |
| electronic portal imaging | Procedure | — | UNRESOLVED |
| image-guided adaptive radiation therapy | Radiation | — | UNRESOLVED |
| radiography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- in-room imaging systems
- description
- Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.
- interventionNames
- Procedure: computed tomography
- Procedure: cone-beam computed tomography
- Procedure: radiography
- Procedure: electronic portal imaging
- Radiation: image-guided adaptive radiation therapy
Primary outcomes (3)
- measure
- Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies
- timeFrame
- up to 7 weeks
- description
- The automated patient setup procedure varies between 'OBI', 'CBCT' or 'Exactrac' imaging technologies. Each procedure gives two shifts: 'vertical' and 'lateral'. In the absence of a gold standard, our goal is to compare the shifts recommended by each pair of automated patient setup procedures. Average and Std deviation of vertical and lateral motion from the three systems were computed. P value, 1.00, refers to the test of difference of each system with OBI being more than 2 mm. Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. The reported mean value represents the shift from planned treatment position averaged over all daily treatment setups. A negative mean vertical value indicates the patient was consistently set up posterior to plan; a negative mean lateral value indicates a set up consistently right of plan.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytologic confirmation of head and neck malignancy * Patients who will be treated with definitive radiation therapy or concurrent chemoradiation therapy * Gross tumor volume (GTV) must be visible on CT * All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines Exclusion Criteria: * Pregnant or nursing women may not participate; women of reproductive potential must be offered a pre-treatment pregnancy test and informed of the need to practice an effective contraceptive method * Prior treatment with radiation therapy to the head and neck * Serum creatinine \> 1.5 and/or * Blood urea nitrogen \[BUN\] \> 25 * Treatment with any prior chemotherapy or surgery (excluding diagnostic biopsy) for this malignancy * Patients with known syndromes expected to alter radiosensitivity (e.g. ataxia-telangiectasia, scleroderma, lupus, human immunodeficiency virus \[HIV\]/acquired immunodeficiency deficiency syndrome \[AIDS\]) may not participate
References
Publications (0)
Data not yet available
No reference posted for this study.