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

NCT01827709 | Terminated

• 1 other identifier: S54730
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

DWI; ADC; DCE-MRI; FDG-PET; SUV; Hypoxia; Head and neck squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Correlation of functional imaging with tumor hypoxia.

  The correlation of DWI, DCE-MRI and FDG-PET with the spatial distribution of hypoxia in patients with head and neck cancer.

  2 years after start of the study.

Interventions

A polymerase chain reaction -based hypoxia classifier OTHER

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.

Functional imaging before treatment. OTHER

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.

Immunohistochemical staining OTHER

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.

MRI of the resection specimen OTHER

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.

Tumour volume delineation and comparison OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Flemish League Against Cancer: collaborator

Study Sites (1)

Radiation Oncology

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Hypoxia; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Sandra Nuyts, PhD MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, Clinical staff member

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 10, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 3, 2023

Record last verified: 2023-03

Locations

BE (1)