Latest Imaging SPECT System Evaluation Phase 1

Dementia Clinical Trial

— LISSE1  

Official title:

Latest Imaging SPECT System Evaluation Phase 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04704349
• Other study ID #: CHRO-2019-12
• Status: Completed
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: January 27, 2021

Study information

• Verified date: November 2021
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Monocentric study for the evaluation of a whole body CZT scintigraphy system.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 27, 2021
• Est. primary completion date: January 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Collagen Diseases
• Dementia
• Embolism
• Heart Diseases
• Kidney Diseases
• Neoplasms
• Parathyroid Diseases
• Parkinsonian Disorders
• Pulmonary Embolism
• Rheumatic Disease
• Rheumatic Diseases
• Thyroid Diseases

Intervention

Radiation:
• Scintigraphy
The scintigraphy of the patients will be carried out on 2 distinct devices and the images obtained will be compared.

Locations

Country	Name	City	State
France	CHR d'Orleans	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (9)

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. — View 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. Review. — View 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. — View Citation

Loong CY, Anagnostopoulos C. Diagnosis of coronary artery disease by radionuclide myocardial perfusion imaging. Heart. 2004 Aug;90 Suppl 5:v2-9. Review. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0
Secondary	collimator performance	Physical measurements of collimator performance on test object.	Day 0