NCT04776291

Brief Summary

Various imaging modalities are used in medical diagnosis such as MRI, CT and PET. The images are sometimes acquired at different times and in different body positions, and thus need to be aligned for precise diagnosis and treatment planning. Different image modalities provide complementary information about the anatomical structure under study. Image registration techniques enable multimodality images to be projected onto a common coordinate system, so that these images can be aligned and spatial correspondences can be established between the images. This research project aims to investigate the information provided by functional PET and CT images about the tumour environment in lung cancer patients by registering functional PET and CT images with the pathology images acquired from the same patient. On identification of specific region of interest on the functional imaging the investigators will then be able to interrogate the tumour biology. In many cancers, the tumour environment is usually composed of a heterogeneous mass of tissue. The discrimination and classification of the carcinoma substructures is of paramount importance in the radiotherapy planning stage, as a given treatment may be more or less suitable depending on the local characteristics of the tumour. For instance, in hypoxic regions (areas inside the tumour with very low oxygen supply), radiotherapy performs poorly and strategies to intensify treatment to those areas could be investigated. This project will develop a framework for automatic registration of pathology images, which are taken from a surgically extracted lung tumour, with the corresponding PET/CT scan acquired from the patient before surgery. The registration of these images is essential for the evaluation of the performance of different PET radiotracers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 16, 2025

Status Verified

May 1, 2023

Enrollment Period

1.9 years

First QC Date

February 24, 2021

Last Update Submit

April 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 4D PET-CT images aquired

    The patent needs to have one 4D PET-CT scan, this is the only requirement in the study as the surgery they will undertake is part of standard care.

    up to 4 weeks after the PET-CT image is taken.

Study Arms (1)

Recruitment and image processing

EXPERIMENTAL
Radiation: 4D PET-CT Scan

Interventions

The recruited patients will have a 4d PET-CT scan that is additional to the usual care.

Recruitment and image processing

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient diagnosed with primary lung cancer and are due to undergo curative surgical resection of the tumour
  • At least one of the tumour's major axes is larger than 30mm.
  • The main volume of the tumour is located within the lung tissue.
  • Tumour is identified primarily as single mass lesion.

You may not qualify if:

  • Patient is under 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West of Scotland Pet Centre

Glasgow, Glasgow, G12 0XP, United Kingdom

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 24, 2021

First Posted

March 1, 2021

Study Start

June 15, 2022

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

April 16, 2025

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

There is no plan to share patient data.

Locations