Assessing Ultra-low Dose PET/CT and CT-less PET Using a Long Axial Field-of-view PET/CT System

NCT05496920 | Completed DMC

• 1 other identifier: 2022-D0038
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Latest generation extended axial field-of-view (FOV) PET/CT systems offer the potential for substantial reductions in applied radiopharmaceutical necessary for a clinical scan. However, such low-dose examination protocols have yet to be robustly tested or demonstrated to be non-inferior. Furthermore, extended FOV scanners offer the potential for CT-less attenuation correction of the PET emission data, making clinically acceptable ultra-low dose examination protocols with radiation exposures of \< 1 millisievert possible for the first time. The aim of this study is to demonstrate the clinical acceptability of such low and ultra-low dose scanning protocols in a head-to-head prospective study against a full-dose scan using a regular FOV system

Conditions

PET/CT

Keywords

PET/CT, low dose, long-axial field-of-view, extended field-of-view, total-body PET

Outcome Measures

Primary Outcomes (1)

• Intra-rater correlation coefficient

  ICC for Cancer Stage using the union for international cancer control (UICC) TNM (T= tumor, N= nodal stage, M = metastasis) System (8th Edition) for low dose positron emission and computed tomography (LD-PET/CT) exams compared to the standard of care (SOC) full-dose (FD)-PET/CT as assessed by a panel of physicians

  2-6 weeks following scan

Secondary Outcomes (6)

• Intra-rater correlation coefficient

  2-6 weeks following scan

• Lesion uptake

  2-6 weeks following scan

• Image quality

  2-6 weeks following scan

• Subjective quality

  2-6 weeks following scan

• Agreement

  2-6 weeks following scan

Other Outcomes (1)

• Acceptability

  2-6 weeks following scan

Study Arms (1)

Single Arm

EXPERIMENTAL

Patients will receive both a standard of care PET/CT and a low dose PET/CT

Diagnostic Test: FD-PET/CT; Diagnostic Test: LD-PET/CT

Interventions

FD-PET/CT DIAGNOSTIC_TEST

Standard of care PET/CT with full dose (FD) of the radiopharmaceutical

Single Arm

LD-PET/CT DIAGNOSTIC_TEST

Additional low dose PET/CT performed within protocol defined time frame LD-PET/CT with additional ultra-low dose CT-less reconstruction

Single Arm

Eligibility Criteria

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

You may qualify if:

• Individuals undergoing a PET/CT with 18F-FDG for the investigation of known or suspected NSCLC.
• Upper fasting plasma glucose levels of \<8.3 mmol/L (\<150 mg/dL) (as measured \>30 mins prior to the administration of the radiopharmaceutical).

You may not qualify if:

• Patients who are unable to consent to a second study-specific examination
• Patients with claustrophobia requiring medication.
• Patients who commence active treatment of a cancer or other pathology between scans.
• Patients who have not fasted for \> 4 hours prior to the study.
• Insulin dependent diabetics.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital, Universitätsspital Bern

Bern, 3010, Switzerland

Location

Study Officials

• Axel O Rominger, MD

  Inselspital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Scan reviewers will be masked to dose and scan reconstruction method.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will receive first a standard of care PET/CT and then an additional low dose PET/CT. The low dose PET/CT will be reconstructed using a standard CT for attenuation correction (LD-PET/CT) and with a novel CT-less method using transmission data (ultra low dose ULD-PET/CT).

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 11, 2022
• Study Start: May 5, 2022
• Primary Completion: August 8, 2024
• Study Completion: August 8, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)