NCT05463913

Brief Summary

Indeterminate lung nodules (6-15mm) are frequent findings in patients undergoing chest CT scanning, but adequate follow-up imaging is currently not in place to facilitate early detection, diagnosis and decision making regarding treatment. The introduction of long Field-Of-View PET/CT scanners could make a difference in this matter due to the substantial increase in sensitivity allowing optimal image quality. Whether this new technology could provide improved detection and follow-up of indeterminate lung nodules is what we aim to explore in this study.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4 lung-cancer

Timeline
Completed

Started Jul 2022

Typical duration for phase_4 lung-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 22, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

July 13, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

March 7, 2025

Status Verified

January 1, 2025

Enrollment Period

2.9 years

First QC Date

March 22, 2022

Last Update Submit

March 4, 2025

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (3)

  • Description of optimized (in terms of e.g. activity dose needed for injection, time of scan duration, post-processing filtering) static whole-body acquisition and reconstruction protocol by performing semi-quantitative (SUV) analysis.

    Description of optimized (in terms of e.g. activity dose needed for injection, time of scan duration, post-processing filtering) static whole-body acquisition and reconstruction protocol by performing semi-quantitative (SUV) analysis.

    up to 2 years

  • Description of optimized (in terms of e.g. activity dose needed for injection, time of scan duration) dynamic whole-body acquisition and reconstruction protocol by performing kinetic modelling (Patlak, Ki) analysis.

    Description of optimized (in terms of e.g. activity dose needed for injection, time of scan duration) dynamic whole-body acquisition and reconstruction protocol by performing kinetic modelling (Patlak, Ki) analysis.

    up to 2 years

  • Description of optimized breath-hold acquisition and reconstruction protocol by performing semi-quantitative (SUV) analysis and compare with outcomes 1 and 2.

    Description of optimized breath-hold acquisition and reconstruction protocol by performing semi-quantitative (SUV) analysis and compare with outcomes 1 and 2.

    up to 2 years

Secondary Outcomes (1)

  • Inventory of early detection and possibly characterization of indeterminate lung nodules

    up to 2 years

Interventions

18F-FDGDRUG

Patients will receive a single intravenous injection of 3 MBq/kg 18F-FDG

PET/CT imagingRADIATION

Patient will undergo 2 CT acquisitions and multiple PET emission scans.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • able to give informed consent
  • signed informed consent
  • confirmed indeterminate lung nodule(s) of 6-15 mm in size on CT chest imaging
  • routine 18F-FDG PET/CT performed
  • scheduled for biopsy or resection of the lung nodules

You may not qualify if:

  • claustrophobia
  • pregnant or breastfeeding
  • interval of at least 2 weeks between PET scan and last date of systemic anti-cancer therapy to reduce false-negative uptake in lesions
  • radiation therapy of the target lung nodule(s)
  • uncontrolled diabetes mellitus
  • any medical condition potentially hampering conduction of the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Adrienne H Brouwers, MD PhD

    Nuclear Medicine physician

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrienne H Brouwers, MD PhD

CONTACT

+31503613093a.h.brouwers@umcg.nl

Joyce van Sluis, MSc.

CONTACT

+31503610702j.van.sluis@umcg.nl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Masking Details
Blinded for FDG PET/CT conducted for research results.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2022

First Posted

July 19, 2022

Study Start

July 13, 2022

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

March 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)