search
Back to results

Latest Imaging SPECT System Evaluation Phase 1 (LISSE1)

Primary Purpose

Rheumatic Disease, Neoplasms, Parathyroid Diseases

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Scintigraphy
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rheumatic Disease focused on measuring Gamma camera, whole body scan, scintigraphy

Eligibility Criteria

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

Inclusion Criteria:

  • Patients referred to our Nuclear Medicine department for bone, cardiac, pulmonary, thyroid, parathyroid, renal or cerebral perfusion scintigraphy or to DaTSCAN.

Exclusion Criteria:

  • Under 18 years old patients.
  • Pregnant women or at risk of pregnancy.
  • Patients under guardianship
  • Painful patient (EVA>4)
  • Patients in whom a standard examination is not feasible (agitation).

Sites / Locations

  • CHR d'Orleans

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Scintigraphy acquisitions

Arm Description

All patients will undergo scintigraphy on 2 distinct devices and the images obtained will be compared.

Outcomes

Primary Outcome Measures

Rate of images with a score greater than or equal to 4
Rate of images obtaining a score greater than or equal to 4 in visual image quality analysis on a 5-point LIKERT scale.

Secondary Outcome Measures

collimator performance
Physical measurements of collimator performance on test object.

Full Information

First Posted
January 6, 2021
Last Updated
November 2, 2021
Sponsor
Centre Hospitalier Régional d'Orléans
search

1. Study Identification

Unique Protocol Identification Number
NCT04704349
Brief Title
Latest Imaging SPECT System Evaluation Phase 1
Acronym
LISSE1
Official Title
Latest Imaging SPECT System Evaluation Phase 1
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
January 27, 2021 (Actual)
Study Completion Date
January 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

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

5. Study Description

Brief Summary
Monocentric study for the evaluation of a whole body CZT scintigraphy system.
Detailed Description
Monocentric evaluation of performances and clinical interest of a whole body scintigraphic acquisition system with CZT digital detectors. Comparison of image quality and resolution of the new system compared to a reference one, on phantoms and during the acquisition of a wide variety of examinations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Disease, Neoplasms, Parathyroid Diseases, Pulmonary Embolism, Heart Diseases, Thyroid Diseases, Kidney Diseases, Dementia, Parkinsonian Disorders
Keywords
Gamma camera, whole body scan, scintigraphy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients will undergo scintigraphy on 2 distinct devices and the images obtained will be compared.
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scintigraphy acquisitions
Arm Type
Experimental
Arm Description
All patients will undergo scintigraphy on 2 distinct devices and the images obtained will be compared.
Intervention Type
Radiation
Intervention Name(s)
Scintigraphy
Intervention Description
The scintigraphy of the patients will be carried out on 2 distinct devices and the images obtained will be compared.
Primary Outcome Measure Information:
Title
Rate of images with a score greater than or equal to 4
Description
Rate of images obtaining a score greater than or equal to 4 in visual image quality analysis on a 5-point LIKERT scale.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
collimator performance
Description
Physical measurements of collimator performance on test object.
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients referred to our Nuclear Medicine department for bone, cardiac, pulmonary, thyroid, parathyroid, renal or cerebral perfusion scintigraphy or to DaTSCAN. Exclusion Criteria: Under 18 years old patients. Pregnant women or at risk of pregnancy. Patients under guardianship Painful patient (EVA>4) Patients in whom a standard examination is not feasible (agitation).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles METRARD, Dr
Organizational Affiliation
CHR Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'Orleans
City
Orléans
ZIP/Postal Code
45067
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21233190
Citation
Garcia EV, Faber TL, Esteves FP. Cardiac dedicated ultrafast SPECT cameras: new designs and clinical implications. J Nucl Med. 2011 Feb;52(2):210-7. doi: 10.2967/jnumed.110.081323. Epub 2011 Jan 13.
Results Reference
background
PubMed Identifier
25311927
Citation
Garcia EV. Are SPECT measurements of myocardial blood flow and flow reserve ready for clinical use? Eur J Nucl Med Mol Imaging. 2014 Dec;41(12):2291-3. doi: 10.1007/s00259-014-2924-2. No abstract available.
Results Reference
background
PubMed Identifier
24948149
Citation
Slomka PJ, Berman DS, Germano G. New cardiac cameras: single-photon emission CT and PET. Semin Nucl Med. 2014 Jul;44(4):232-51. doi: 10.1053/j.semnuclmed.2014.04.003.
Results Reference
background
PubMed Identifier
30932983
Citation
Bani Sadr A, Testart N, Tylski P, Scheiber C. Reduced Scan Time in 123I-FP-CIT SPECT Imaging Using a Large-Field Cadmium-Zinc-Telluride Camera. Clin Nucl Med. 2019 Jul;44(7):568-569. doi: 10.1097/RLU.0000000000002554.
Results Reference
background
PubMed Identifier
19808630
Citation
Salerno M, Beller GA. Noninvasive assessment of myocardial perfusion. Circ Cardiovasc Imaging. 2009 Sep;2(5):412-24. doi: 10.1161/CIRCIMAGING.109.854893. No abstract available.
Results Reference
background
PubMed Identifier
15446754
Citation
Mowatt G, Vale L, MacLeod A. Systematic review of the effectiveness of home versus hospital or satellite unit hemodialysis for people with end-stage renal failure. Int J Technol Assess Health Care. 2004 Summer;20(3):258-68. doi: 10.1017/s0266462304001060.
Results Reference
background
PubMed Identifier
15254003
Citation
Loong CY, Anagnostopoulos C. Diagnosis of coronary artery disease by radionuclide myocardial perfusion imaging. Heart. 2004 Aug;90 Suppl 5(Suppl 5):v2-9. doi: 10.1136/hrt.2003.013581. No abstract available.
Results Reference
background
PubMed Identifier
20920635
Citation
Roach PJ, Gradinscak DJ, Schembri GP, Bailey EA, Willowson KP, Bailey DL. SPECT/CT in V/Q scanning. Semin Nucl Med. 2010 Nov;40(6):455-66. doi: 10.1053/j.semnuclmed.2010.07.005.
Results Reference
background
PubMed Identifier
30128693
Citation
Valotassiou V, Malamitsi J, Papatriantafyllou J, Dardiotis E, Tsougos I, Psimadas D, Alexiou S, Hadjigeorgiou G, Georgoulias P. SPECT and PET imaging in Alzheimer's disease. Ann Nucl Med. 2018 Nov;32(9):583-593. doi: 10.1007/s12149-018-1292-6. Epub 2018 Aug 20.
Results Reference
background

Learn more about this trial

Latest Imaging SPECT System Evaluation Phase 1

We'll reach out to this number within 24 hrs