NCT06424873

Brief Summary

The goal of this clinical trial is to to achieve robust quantitative whole- body parametric imaging in clinically feasible scan times in patient with oncologic pathology . The main question\[s\] it aims to answer are:

  • \[question 1\]
  • \[question 2\] Participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\].

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Apr 2024

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

November 9, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

1.8 years

First QC Date

November 9, 2023

Last Update Submit

May 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Standard SUV measurement metric

    The standard SUV measurement metric will be compared with the measured influx rate Ki as obtained from dynamic PET/CT imaging for FDG-avid processes. We expect a correlation coefficient of at least 0.8.

    through study completion , an average of 2 years

Secondary Outcomes (2)

  • Image quality

    through study completion , an average of 2 years

  • Certainty in diagnosis of FDG-avid processes

    through study completion , an average of 2 years

Study Arms (1)

One arm study

EXPERIMENTAL

Additionnal images during PET/CT

Radiation: PET/CT with FDG or FES

Interventions

The study consists of an additional 50 minutes of imaging during the radiotracer's uptake phase prior to their clinical scan (standard of care).

One arm study

Eligibility Criteria

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

You may qualify if:

  • Patients clinically indicated for whole-body PET evaluation.
  • Patient must agree to lie still in the camera.
  • Patient must be able to comply with study procedures.
  • Patient must be able to provide informed consent.

You may not qualify if:

  • Patients \< 18 years of age.
  • Pregnant women are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospitals

Geneva, 1205, Switzerland

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Fluorodeoxyglucose F18proto-oncogene protein c-fes-fps

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Central Study Contacts

Valentina Garibotto, Pr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: PET/CT
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of the Division of Nuclear Medicine and Molecular imaging

Study Record Dates

First Submitted

November 9, 2023

First Posted

May 22, 2024

Study Start

April 1, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 22, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations