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Correlation of Pre- and Post-operative Cancer Imaging Techniques

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
4D PET-CT Scan
Sponsored by
University of Strathclyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Lung Cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patient is under 18 years old.

Sites / Locations

  • West of Scotland Pet CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Recruitment and image processing

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 24, 2021
Last Updated
May 11, 2023
Sponsor
University of Strathclyde
Collaborators
NHS Greater Glasgow and Clyde
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1. Study Identification

Unique Protocol Identification Number
NCT04776291
Brief Title
Correlation of Pre- and Post-operative Cancer Imaging Techniques
Official Title
PET-PATH: Investigation of New Medical Imaging Techniques for Improving Lung Cancer Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Strathclyde
Collaborators
NHS Greater Glasgow and Clyde

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recruitment and image processing
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
4D PET-CT Scan
Intervention Description
The recruited patients will have a 4d PET-CT scan that is additional to the usual care.
Primary Outcome Measure Information:
Title
4D PET-CT images aquired
Description
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.
Time Frame
up to 4 weeks after the PET-CT image is taken.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Patient is under 18 years old.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew R M Gil, MSc
Phone
+447751152132
Email
matthew.gil@strath.ac.uk
Facility Information:
Facility Name
West of Scotland Pet Centre
City
Glasgow
ZIP/Postal Code
G12 0XP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Gil
Phone
+447751152142
Email
matthew.gil@strath.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share patient data.

Learn more about this trial

Correlation of Pre- and Post-operative Cancer Imaging Techniques

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