Head and Neck CancerNCT04360993
Role of PET/MRI in Head and Neck Cancer
An observational study of Head and Neck Cancer and Benign Neoplasm, run by University of Pecs.
Trial summary
Study aim was to investigate the diagnostic role of Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) in head and neck cancer. Read more about this study
- Who is it for?
- Ages 41 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer, Benign Neoplasm, Malignant Neoplasm
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 12 Apr 2016to 22 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 88 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population were patients who have been diagnosed with head and neck cancer.
Who may be able to join
- Proved Head and neck cancer
- Underwent PET/CT and PET/MRI
- Lymph nodes due to primary Head and neck cancer.
- For healthy subject:
- No previous history of malignancy.
- no inflammation or infection in the neck region.
- lymph node size <10mm.
Who cannot join
- patients treated before by radiotherapy / chemoradiotherapy
- patients underwent surgery
- artifacts
About this study
Official title: PET/CT and PET/MRI Based Treatment Modalities in the Modern Oncology
Study aim was to investigate the diagnostic role of Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) in head and neck cancer.
Read the detailed description
This study was assessed the role of Diffusion weighted imaging (DWI) in discriminating between benign and malignant lesions in Head and neck cancer as well as studying the relationship between glucose metabolism (18F-FDG) and Apparent diffusion coefficient (ADC) for better tumor assessment.
- Conditions
- Head and Neck Cancer, Benign Neoplasm, Malignant Neoplasm
- Being tested
- Radiotherapy
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Patients have received radiotherapy as a treatment modality for Head and neck cancer
| Study group | Role | What they receive |
|---|---|---|
| Patients underwent PET/CT & PET/MRI | Patients with head and neck cancer were underwent PET/CT and PET/MRI for staging, assessment and follow up Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Apparent diffusion coefficient value between benign and malignant lesions
Apparent diffusion coefficient (ADC) was measured from benign and malignant lymph nodes by drawing region of interest (ROI) on the most homogeneous and most solid part in the target lymph node. Higher ADC value in Benign lymph node means that there are more water molecules movement inside the lymph node, more water molecules movement resulting in higher Apparent diffusion coefficient value. in malignant nodes and due to more tumor tissue, the result is to have lower water molecules motion so, lower ADC value.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start12 Apr 2016
- Primary completion9 Aug 2019
- Study completion22 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Freihat, University of Pecs
- Investigators
- Arpad Kovacs, MD, PhD, Study director, University of PecsCselik Zsolt, MD, PhD, Study chair, Csolnoky Ferenc Kórház, Veszprém, HungaryOmar Freihat, Principal investigator, Doctoral school of health sciences, Pécs University, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360993
- Sponsor's protocol ID
- Pécs/ Oncoradiology
- Status last verified
- Dec 2020
- First submitted
- 17 Apr 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Variable used in the study.
Publications
Freihat O, Toth Z, Pinter T, Kedves A, Sipos D, Cselik Z, Lippai N, Repa I, Kovacs A. Pre-treatment PET/MRI based FDG and DWI imaging parameters for predicting HPV status and tumor response to chemoradiotherapy in primary oropharyngeal squamous cell carcinoma (OPSCC). Oral Oncol. 2021 May;116:105239. doi: 10.1016/j.oraloncology.2021.105239. Epub 2021 Feb 25.
PubMed 33640578Freihat O, Pinter T, Kedves A, Sipos D, Cselik Z, Repa I, Kovacs A. Diffusion-Weighted Imaging (DWI) derived from PET/MRI for lymph node assessment in patients with Head and Neck Squamous Cell Carcinoma (HNSCC). Cancer Imaging. 2020 Aug 8;20(1):56. doi: 10.1186/s40644-020-00334-x.
PubMed 32771060
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/CT and PET/MRI Based Treatment Modalities in the Modern Oncology
- ClinicalTrials.gov ID
- NCT04360993
- Acronym / sponsor ID
- Pécs/ Oncoradiology
- Conditions
- Head and Neck Cancer, Benign Neoplasm, Malignant Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 12 Apr 2016 (actual)
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study aim was to investigate the diagnostic role of Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) in head and neck cancer.
Detailed description
This study was assessed the role of Diffusion weighted imaging (DWI) in discriminating between benign and malignant lesions in Head and neck cancer as well as studying the relationship between glucose metabolism (18F-FDG) and Apparent diffusion coefficient (ADC) for better tumor assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients underwent PET/CT & PET/MRI | – | Radiation: RadiotherapyPatients with head and neck cancer were underwent PET/CT and PET/MRI for staging, assessment and follow up |
Who may qualify
- Ages
- 41 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population were patients who have been diagnosed with head and neck cancer.
Key inclusion criteria (7 listed)
- Proved Head and neck cancer
- Underwent PET/CT and PET/MRI
- Lymph nodes due to primary Head and neck cancer.
- No previous history of malignancy.
- no inflammation or infection in the neck region.
Key exclusion criteria (3 listed)
- patients treated before by radiotherapy / chemoradiotherapy
- patients underwent surgery
- artifacts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyPatients have received radiotherapy as a treatment modality for Head and neck cancer | Radiation | Patients underwent PET/CT & PET/MRI |
Primary outcome
Difference in Apparent diffusion coefficient value between benign and malignant lesions
Time frame: Baseline
Apparent diffusion coefficient (ADC) was measured from benign and malignant lymph nodes by drawing region of interest (ROI) on the most homogeneous and most solid part in the target lymph node. Higher ADC value in Benign lymph node means that there are more water molecules movement inside the lymph node, more water molecules movement resulting in higher Apparent diffusion coefficient value. in malignant nodes and due to more tumor tissue, the result is to have lower water molecules motion so, lower ADC value.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Derived from this study: PubMed 33640578Freihat O, Toth Z, Pinter T, Kedves A, Sipos D, Cselik Z, Lippai N, Repa I, Kovacs A. Pre-treatment PET/MRI based FDG and DWI imaging parameters for predicting HPV status and tumor response to chemoradiotherapy in primary oropharyngeal squamous cell carcinoma (OPSCC). Oral Oncol. 2021 May;116:105239. doi: 10.1016/j.oraloncology.2021.105239. Epub 2021 Feb 25.
- Derived from this study: PubMed 32771060Freihat O, Pinter T, Kedves A, Sipos D, Cselik Z, Repa I, Kovacs A. Diffusion-Weighted Imaging (DWI) derived from PET/MRI for lymph node assessment in patients with Head and Neck Squamous Cell Carcinoma (HNSCC). Cancer Imaging. 2020 Aug 8;20(1):56. doi: 10.1186/s40644-020-00334-x.
- Individual participant dataSharing planned: Yes. Variable used in the study.
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
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RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
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RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arpad Kovacs, MD, PhD study director
University of Pecs
Cselik Zsolt, MD, PhD study chair
Csolnoky Ferenc Kórház, Veszprém, Hungary
Omar Freihat principal investigator
Doctoral school of health sciences, Pécs University, Hungary
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Benign Neoplasm, run by University of Pecs.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Apparent diffusion coefficient value between benign and malignant lesions (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04360993, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.