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Pathological Validation of Functional Imaging in Head and Neck Squamous Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01827709
Recruitment Status : Terminated (poor accrual)
First Posted : April 10, 2013
Last Update Posted : April 3, 2023
Flemish League Against Cancer
Information provided by (Responsible Party):
Dr. Sandra Nuyts, Universitaire Ziekenhuizen KU Leuven

Brief Summary:

Chemo-radiotherapy (CRT) is currently the cornerstone in the management of locoregional advanced head and neck cancer (HNC). Optimization of the quality of RT is therefore an important issue, if the investigators want to improve the therapeutic index in HNC. This could be achieved by a more accurate definition of the tumor volume and by identification of radioresistant volumes within the tumor. Recent literature puts in this regard the incorporation of functional imaging (FI) in the RT treatment planning forward as a promising tool.

FI modalities provide an outstanding contrast between tumor and surrounding tissues. This is in contrast to anatomical imaging. Using anatomical imaging in RT treatment planning, sufficient margins need to be placed around the tumor volume in order to compensate for geometric uncertainties. Consequently many surrounding functional structures receive high doses of irradiation, resulting in side effects. It is expected that, using FI in RT treatment planning will make these margins smaller or even unnecessary, which will result in less irradiation of the surrounding tissues. So far only one study has reported a comparison between tumor volume on anatomical (CT and MRI) and FI (PET-CT) modalities with pathological tumor volume. This study showed indeed that the tumor volumes delineated on PET-CT correlated more to tumor volumes defined by pathology and were significantly smaller.

Furthermore, FI provides us with a deeper insight in the tumor's underlying biological activity and microstructure. These techniques can thus help to identify radioresistant subvolumes which might benefit from treatment intensification.

A validation of these FI modalities with pathology is necessary to investigate their true power in tumor delineation and in the identification of radioresistant subvolumes.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Other: A polymerase chain reaction -based hypoxia classifier Other: Functional imaging before treatment. Other: Immunohistochemical staining Other: MRI of the resection specimen Other: Tumour volume delineation and comparison Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pathological Validation of Functional Imaging in Head and Neck Squamous Cell Carcinoma. A Prospective, Non-commercial and Mono-centric Study
Study Start Date : March 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: A polymerase chain reaction -based hypoxia classifier

    Recently, a polymerase chain reaction (PCR) -based hypoxia classifier gene signature was published that can be easily applied. Using this classifier, patients will be divided in hypoxic or non-hypoxic subgroups.

    These subgroups will be correlated to locoregional control. The hypoxic signature will also be related to parameters on DCE-MRI, DWI and FDG-PET.

  • Other: Functional imaging before treatment.
    As part of the standard staging procedure all patients will undergo an MRI of the neck. We will however also take DWI and DCE images at this time point. Parameters of these images will be later on correlated with pathology.
  • Other: Immunohistochemical staining
    At 3 levels of the tumour, chosen by the radiologist on the functional imaging modalities, 4µm thick slices will me taken. On each level an immunohistochemical staining will be carried out (GLUT-1, CA-IX, HIF-1alpha, VEGF, KI 67). The result of this staining will be correlated with parameters derived from the functional imaging modalities.
  • Other: MRI of the resection specimen
    To account for the shrinkage of the tumour due to fixation, the resection specimen will be placed in a box and scanned with an MRI. From this a shrinkage factor will be calculated using the original pre-treatment MRI.
  • Other: Tumour volume delineation and comparison
    On the imaging modalities the tumor volume will be delineated. This will also be done on the resection specimen. Later on the different tumour volumes will be correlated.

Primary Outcome Measures :
  1. Correlation of functional imaging with tumor hypoxia. [ Time Frame: 2 years after start of the study. ]
    The correlation of DWI, DCE-MRI and FDG-PET with the spatial distribution of hypoxia in patients with head and neck cancer.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma of the larynx (preferably tumours located within the bone structures of the larynx)
  • Decision of primary surgery with curative intent made by the multidisciplinary group of head and neck tumours at Leuven University Hospital
  • Karnofsky performance status ≥70%
  • Age ≥ 18 years old
  • Gender: Male - Female
  • Informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

  • Prior irradiation to the head and neck region
  • Medical contraindications for any of the planned investigations
  • Distant metastases
  • Pregnant or lactating women
  • Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study
  • Patient unlikely to comply with the protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01827709

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Radiation Oncology
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen KU Leuven
Flemish League Against Cancer
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Principal Investigator: Sandra Nuyts, PhD MD Universitaire Ziekenhuizen KU Leuven
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Responsible Party: Dr. Sandra Nuyts, Full Professor, Clinical staff member, Universitaire Ziekenhuizen KU Leuven Identifier: NCT01827709    
Other Study ID Numbers: S54730
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: April 3, 2023
Last Verified: March 2023
Keywords provided by Dr. Sandra Nuyts, Universitaire Ziekenhuizen KU Leuven:
Head and neck squamous cell carcinoma
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site