NCT04704349

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 5, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2021

Completed
Last Updated

November 3, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

January 6, 2021

Last Update Submit

November 2, 2021

Conditions

Keywords

Gamma camerawhole body scanscintigraphy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • collimator performance

    Day 0

Study Arms (1)

Scintigraphy acquisitions

EXPERIMENTAL

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

Radiation: Scintigraphy

Interventions

ScintigraphyRADIATION

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

Scintigraphy acquisitions

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR d'Orleans

Orléans, 45067, France

Location

Related Publications (9)

  • 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.

    PMID: 21233190BACKGROUND
  • 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.

    PMID: 25311927BACKGROUND
  • 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.

    PMID: 24948149BACKGROUND
  • 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.

    PMID: 30932983BACKGROUND
  • 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.

    PMID: 19808630BACKGROUND
  • 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.

    PMID: 15446754BACKGROUND
  • 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.

    PMID: 15254003BACKGROUND
  • 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.

    PMID: 20920635BACKGROUND
  • 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.

    PMID: 30128693BACKGROUND

MeSH Terms

Conditions

Rheumatic DiseasesNeoplasmsParathyroid DiseasesPulmonary EmbolismHeart DiseasesThyroid DiseasesKidney DiseasesDementiaParkinsonian Disorders

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesEndocrine System DiseasesLung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBasal Ganglia DiseasesMovement Disorders

Study Officials

  • Gilles METRARD, Dr

    CHR Orléans

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: All patients will undergo scintigraphy on 2 distinct devices and the images obtained will be compared.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 11, 2021

Study Start

October 5, 2020

Primary Completion

January 27, 2021

Study Completion

January 27, 2021

Last Updated

November 3, 2021

Record last verified: 2021-11

Locations