Photoacoustic Imaging of Head and Neck Tumours

NCT05073809 | Withdrawn DMC

• 1 other identifier: 123718
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cancer is the commonest cause of death in the UK, and a national and international healthcare priority. Survival in the UK is relatively poor vs. European comparators1, meaning early tumour detection and accurate clinical assessment is particularly important to improve outcomes. Treatment fundamentally depends on tumour staging, both of the local cancer and of draining lymph nodes (LN), as well as distant spread of disease i.e. TNM stage (tumour (T), node (N) and metastases (M). However, current non-invasive pre-operative imaging technologies of ultrasound (US), computed tomography (CT) and magnetic resonance imaging (MRI) are limited in sensitivity and specificity for nodal assessment, either missing disease or subjecting patients to unnecessary additional invasive biopsies or surgery. A simple, rapid, non-invasive tool to assess primary tumours and LN involvement would be of great clinical value. One candidate technology is photoacoustic tomography (PAT), a relatively novel modality that combines exquisite spatial resolution with the ability to image multiple biological tissues, including blood, water and lipid. To date, PAT has been most successful in imaging the vasculature, which is of particular interest for oncological imaging because one of the key hallmarks of cancer is the development of new, abnormal blood vessels (neoangiogenesis). The high sensitivity for superficial imaging with PAT means that head and neck tumours and neck LN are readily amenable for assessment. In this cohort of patients, those with oral cavity tumours, in particular tumours arising from the lining of the tongue, would be readily accessible for direct scanning.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Group 2

  the primary outcome is to identify the proportion of participants with oral cavity cancer in whom DOI can be successfully measured with PAT i.e. technical success. The outcome is to measure the success of the photoacoustic scanner.

  3 years

Study Arms (2)

Group 1

Proven or highly suspected head and neck tumour undergoing routine clinical staging of their neck LN status

Diagnostic Test: Photoacoustic Imaging Scan

Group 2

Proven or suspected oral cavity cancer, amenable to intraoral examination

Diagnostic Test: Photoacoustic Imaging Scan

Interventions

Photoacoustic Imaging Scan DIAGNOSTIC_TEST

A relatively novel modality that combines exquisite spatial resolution with the ability to image multiple biological tissues, including blood, water and lipid.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Head and neck tumours

You may qualify if:

• Proven or highly suspected to have a head and neck tumour, including oral cavity cancer, and/or abnormal LN in the head and neck (on the basis of physical examination or medical imaging).
• years or older (no upper age limit).

You may not qualify if:

• Unable to provide informed written informed consent (e.g. dementia, significant mental illness, brain metastases).
• Severe skin or mucosal disease precluding safe, comfortable placement of the US or PAT probes (e.g. active infection; ulcerating tumour).
• Contraindication to MRI magnetic field e.g. non-MRI compatible pacemaker, cochlear implant, severe claustrophobia, or allergy to MRI contrast agent (Gadolinium)
• Restricted mouth opening in those patients with an oral cavity neoplasm

Sponsors & Collaborators

• University College, London: lead

Related Publications (3)

• Sant M, Allemani C, Santaquilani M, Knijn A, Marchesi F, Capocaccia R; EUROCARE Working Group. EUROCARE-4. Survival of cancer patients diagnosed in 1995-1999. Results and commentary. Eur J Cancer. 2009 Apr;45(6):931-91. doi: 10.1016/j.ejca.2008.11.018. Epub 2009 Jan 24.

  PMID: 19171476 BACKGROUND

• Abu-Ghanem S, Yehuda M, Carmel NN, Leshno M, Abergel A, Gutfeld O, Fliss DM. Elective Neck Dissection vs Observation in Early-Stage Squamous Cell Carcinoma of the Oral Tongue With No Clinically Apparent Lymph Node Metastasis in the Neck: A Systematic Review and Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2016 Sep 1;142(9):857-65. doi: 10.1001/jamaoto.2016.1281.

  PMID: 27442962 BACKGROUND

• Mizrachi A, Migliacci JC, Montero PH, McBride S, Shah JP, Patel SG, Ganly I. Neck recurrence in clinically node-negative oral cancer: 27-year experience at a single institution. Oral Oncol. 2018 Mar;78:94-101. doi: 10.1016/j.oraloncology.2018.01.020. Epub 2018 Feb 20.

  PMID: 29496065 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 12, 2021
• Study Start: September 29, 2022
• Primary Completion: September 29, 2022
• Study Completion: September 29, 2022
• Last Updated: October 27, 2023

Record last verified: 2023-10