Data Collection Study for the Spectrum Dynamics Multi-purpose CZT SPECT Camera

NCT03438123 | Completed

• 1 other identifier: SD-MPC-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates SPECT image data acquired from Spectrum Dynamics' multi-purpose CZT SPECT-CT camera. All subjects will undergo routine clinical Anger SPECT imaging and an additional SPECT acquisition on the CZT SPECT camera. Additionally some subjects will undergo CT on the CZT SPECT-CT camera. The quality of images from each device will be compared.

Conditions

Dementia; Parkinson Disease; Pulmonary Hypertension; Heart Diseases; Paget Disease; Bone Diseases; Bone Fracture; Renal Disease; Pulmonary Embolism; Bone Lesion

Outcome Measures

Primary Outcomes (2)

• CZT SPECT Image Acquisition

  Technical adequacy of acquired CZT SPECT images for demonstrating the location and distribution of gamma ray radionuclides within the body

  1 day

• CZT SPECT-CT Image Acquisition

  Technical adequacy of acquired CZT SPECT-CT images for demonstrating the location and distribution of gamma ray radionuclides within the body

  1 day

Secondary Outcomes (8)

• CZT SPECT Image Quality

  1 day

• Comparative Quality of CZT and Anger SPECT Images

  1 day

• Safety of the CZT SPECT Camera

  Through study completion; anticipated to be 24 months

• Safety of the CZT SPECT Camera During Imaging Procedures

  1 day

• CZT SPECT-CT Image Quality

  1 day

Study Arms (1)

CZT SPECT

EXPERIMENTAL

CZT SPECT imaging with/without the addition of CT on the Spectrum Dynamics camera

Device: CZT SPECT imaging

Interventions

CZT SPECT imaging DEVICE

Acquisition of SPECT (single photon emission computed tomography) imaging utilising a camera system with solid-state cadmium zinc telluride (CZT) detectors to visualise injected, or otherwise introduced, radioactivity in the human body.

CZT SPECT

Eligibility Criteria

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

You may qualify if:

• Patient is clinically referred for scintigraphy using a radiopharmaceutical in the energy range of 40 - 220 keV emission
• Patient is aged ≥18 years
• Patient condition is stable
• Patient is willing and able to undergo image acquisition on the MPC CZT SPECT camera with integrated CT in addition to standard clinical scintigraphy procedure
• Patient must be willing and able to provide written informed consent
• Patient must be affiliated to a social security scheme

You may not qualify if:

• Patient with unstable medical condition
• Patient is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
• Patient is contra-indicated to undergo the scintigraphy imaging procedure for which they have been clinically referred

Sponsors & Collaborators

• Spectrum Dynamics: lead
• University Hospital, Caen: collaborator

Study Sites (1)

CHU de Caen

Caen, Normandy, 14033, France

Location

MeSH Terms

Conditions

Dementia; Parkinson Disease; Hypertension, Pulmonary; Heart Diseases; Bone Diseases; Fractures, Bone; Kidney Diseases; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Musculoskeletal Diseases; Wounds and Injuries; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Embolism; Embolism and Thrombosis

Study Officials

• Denis Agostini, MD.PhD

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects undergo baseline clinically referred routine nuclear scintigraphy imaging and sequential imaging on the CZT SPECT investigational device following a single dose of radiopharmaceutical. Some subjects will additionally undergo CT on the CZT SPECT-CT investigational device.

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 19, 2018
• Study Start: November 28, 2017
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: October 21, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)