Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT05049551
Status:
COMPLETED
Last Update Posted:
2021-09-20
First Post:
2021-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thyroid Uptake Quantification on a New Generation of Gamma Camera
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-09', 'studyFirstSubmitDate': '2021-09-09', 'studyFirstSubmitQcDate': '2021-09-09', 'lastUpdatePostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thyroid uptake', 'timeFrame': 'Inclusion', 'description': 'Quantification of thyroid uptake'}], 'secondaryOutcomes': [{'measure': 'SPECT/CT', 'timeFrame': 'Inclusion', 'description': 'Diagnostic contribution of SPECT/CT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thyroid', 'uptake', 'quantification', 'CZT', 'Planar', 'SPECT/CT'], 'conditions': ['Hyperthyroidism']}, 'referencesModule': {'references': [{'pmid': '21484383', 'type': 'BACKGROUND', 'citation': 'Ritt P, Vija H, Hornegger J, Kuwert T. Absolute quantification in SPECT. Eur J Nucl Med Mol Imaging. 2011 May;38 Suppl 1:S69-77. doi: 10.1007/s00259-011-1770-8. Epub 2011 Apr 12.'}, {'pmid': '28096891', 'type': 'BACKGROUND', 'citation': 'Gnesin S, Leite Ferreira P, Malterre J, Laub P, Prior JO, Verdun FR. Phantom Validation of Tc-99m Absolute Quantification in a SPECT/CT Commercial Device. Comput Math Methods Med. 2016;2016:4360371. doi: 10.1155/2016/4360371. Epub 2016 Dec 14.'}, {'pmid': '31392371', 'type': 'BACKGROUND', 'citation': 'Giovanella L, Avram AM, Iakovou I, Kwak J, Lawson SA, Lulaj E, Luster M, Piccardo A, Schmidt M, Tulchinsky M, Verburg FA, Wolin E. EANM practice guideline/SNMMI procedure standard for RAIU and thyroid scintigraphy. Eur J Nucl Med Mol Imaging. 2019 Nov;46(12):2514-2525. doi: 10.1007/s00259-019-04472-8. Epub 2019 Aug 7.'}, {'pmid': '33008929', 'type': 'BACKGROUND', 'citation': 'Mariani G, Tonacchera M, Grosso M, Orsolini F, Vitti P, Strauss HW. The Role of Nuclear Medicine in the Clinical Management of Benign Thyroid Disorders, Part 1: Hyperthyroidism. J Nucl Med. 2021 Mar;62(3):304-312. doi: 10.2967/jnumed.120.243170. Epub 2020 Oct 2.'}, {'pmid': '37522931', 'type': 'DERIVED', 'citation': 'Serrano B, Amblard R, Beaumont T, Hugonnet F, Dietz M, Berthier F, Garnier N, Villeneuve R, Nataf V, Mocquot F, Montemagno C, Faraggi M, Paulmier B. Quantitative analysis of 99mTc-pertechnetate thyroid uptake with a large-field CZT gamma camera: feasibility and comparison between SPECT/CT and planar acquisitions. EJNMMI Phys. 2023 Jul 31;10(1):45. doi: 10.1186/s40658-023-00566-3.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the potential of a new large field CZT gamma camera to estimate the thyroid uptake (TU) on Single photon emission computed tomography (SPECT) and SPECT/CT images in comparison with standard planar scintigraphy.\n\nThe secondary objective is to analyze the diagnostic contribution of SPECT/CT imaging.', 'detailedDescription': 'Planar and SPECT/CT scintigraphy will be performed on a new generation large field CZT gamma camera and thyroid uptake (TU) value will be calculated on planar acquisition for 23 consecutive patients referred in our department for hyperthyroidism.\n\nWith a quantitative approach using attenuation, scatter correction and iterative algorithm with resolution recovery we will have the possibility to calculate the TU value with SPECT or SPECT/CT acquisitions.\n\nOur primary objective will be to evaluate the potential of a new large field CZT gamma camera to estimate the thyroid uptake on SPECT (Tomography without attenuation correction) and SPECT/CT (tomography with attenuation correction) acquisitions compared with standard planar scintigraphy as a gold standard.\n\nThe secondary objective will be to analyze the diagnostic contribution of SPECT/CT images.\n\nTo established this study it will be necessary to introduce cross-calibration factors performed from a thyroid phantom, for planar and SPECT acquisitions, to estimate the thyroid uptake values.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Twenty-three consecutive participants referred in our nuclear medicine department for hyperthyroidism', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hyperthyroidism confirmed by blood test (TSH) and thyroid ultrasound\n\nExclusion Criteria:\n\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT05049551', 'acronym': 'QUANTHYC', 'briefTitle': 'Thyroid Uptake Quantification on a New Generation of Gamma Camera', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Princesse Grace'}, 'officialTitle': 'Quantitative Analysis of 99mTc-Pertechnetate Thyroid Uptake With a Large Field CZT Gamma Camera: Feasibility and Comparison Between SPECT/CT and Planar Acquisitions', 'orgStudyIdInfo': {'id': '21-09'}}, 'contactsLocationsModule': {'locations': [{'zip': '98000', 'city': 'Monaco', 'country': 'Monaco', 'facility': 'Centre Hospitalier Princesse Grace', 'geoPoint': {'lat': 43.73718, 'lon': 7.42145}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Princesse Grace', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}