Evaluatie van 18F-TFB PET/CT-scan bij patiënten met gedifferentieerde schildklierkanker
Evaluatie van F-18-tetrafluorboraat (18F-TFB) PET/CT bij patiënten met gedifferentieerde schildklierkanker
This phase II study evaluates F-18 tetrafluoroborate (18F-TFB) PET/CT scan in patients with differentiated thyroid cancer. Diagnostic imaging is necessary for planning treatment, monitoring therapy response, and identifying sites of recurrent or metastatic disease in differentiated thyroid cancer. 18F-TFB PET/CT may accurately detect recurrent and metastatic thyroid cancer lesions, with the potential to provide information for patient management that is better than the current standard of care imaging practices.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
PRIMARY OBJECTIVES:
I. Evaluate fluorine F 18 tetrafluoroborate (18F-TFB) positron emission tomography (PET)/computed tomography (CT) imaging in patients with intermediate or high risk differentiated thyroid cancer (DTC) and compare to the current clinical standard.
II. Assess the impact of 18F-TFB PET/CT on clinical management.
OUTLINE:
Patients receive fluorine F 18 tetrafluoroborate intravenously (IV) and undergo PET/CT scan on study.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Minnesota
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic in Rochester
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Subjects have biopsy-proven papillary or follicular thyroid cancer and is clinically indicated for 123I-single-photon emission computerized tomography (I-SPECT)/CT total body iodine (TBI) scan
Beschrijving
Inclusion Criteria:
- Subject has biopsy-proven papillary or follicular thyroid cancer
- Subject is clinically indicated for 123I-SPECT/CT total body iodine (TBI) scan
- Subject agrees to undergo 18F-TFB PET/CT scan following TBI scan
- Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)
- Subject is able to be scanned - able to lie still on SPECT/CT and PET/CT scanner table for up to 65 minutes (min)
- Age 18 or older
- Ability to understand a written informed consent document, and the willingness to sign it
- Subject is not pregnant
Exclusion Criteria:
- Contrast-enhanced CT within 4 last weeks
- Amiodarone within last 4 months
- Ingested iodine, kelp tablets, Lugols iodine, or potassium iodide (SSKI) within 2 weeks
- Unable to lie flat, still or tolerate a PET scan
- Applied betadine, iodoform, or quick tanning products to skin within last two weeks
- If using medication withdrawal for stimulation, then exclude if thyroid stimulating hormone (TSH) level < 25
- Taken anti-thyroid medication within 1 week
- Subject is breastfeeding
- Positive pregnancy test
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Observational (18F-TFB PET/CT)
Patients receive fluorine F18 tetrafluoroborate IV and undergo PET/CT scan on study. |
Ancillary studies Undergo a PET/CT scan
Andere namen:
Given IV
Andere namen:
Undergo a PET/CT scan
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Descriptive summaries of detected lesions
Tijdsspanne: Up to 2 years
|
Descriptive summaries of detected lesions (presence/absence) will include counts and proportions at the patient and lesion level. Overall concordance of these measures across modalities will be estimated using Cohen's kappa with 95% confidence intervals generated by clustered bootstrapping. Per-lesion analysis of detection rates by modality will be performed using cluster-adjusted McNemar's test, accounting for the paired nature of the data (i.e., two scans) and potential within-sample correlation for patients with multiple lesions. |
Up to 2 years
|
|
Conspicuities and diagnostic confidence scores for a given lesion
Tijdsspanne: Up to 2 years
|
Conspicuities and diagnostic confidence scores for a given lesion will be averaged across readers. Descriptive summaries of these scores will include medians and interquartile ranges. Concordance of these measures across modality will be evaluated using Lin's concordance correlation coefficient with 95% confidence intervals generated by clustered bootstrapping. Differences in conspicuities and diagnostic confidence scores will be tested using cluster-adjusted Wilcoxon signed-rank tests. |
Up to 2 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
True positive and negative lesions
Tijdsspanne: Up to 2 years
|
Given true positive and negative lesions determined by histopathology and/or imaging, clinical and laboratory follow-up, we will estimate sensitivity, specificity, net present value, and positive predictive value on a per-lesion and patient basis for 18F TFB PET/CT and 123I single-photon emission computerized tomography/CT along with the corresponding two-sided 95% confidence intervals. The confidence intervals will be constructed using clustered bootstrapping. |
Up to 2 years
|
|
Impact of PET on clinical management in differentiated thyroid cancer (DTC) patients
Tijdsspanne: Up to 2 years
|
The impact of PET on clinical management in DTC patients will be evaluated using descriptive statistics. Evidence of discordance among the modalities will be assessed using a McNemar- Bowker test of symmetry. |
Up to 2 years
|
|
Inter-reader reproducibility
Tijdsspanne: Up to 2 years
|
Inter-reader reproducibility will be assessed for positivity at the patient level and region level (nominal) as well as standardized uptake values (SUVs) for positive lesions (quantitative). Reproducibility will be reported using the Fleiss' Kappa test for multiple readers for positivity and Pearson intra-class correlation for SUVs. |
Up to 2 years
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Stephen M. Broski, M.D., Mayo Clinic in Rochester
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Endocriene systeemziekten
- Neoplasmata per site
- Neoplasmata
- Neoplasmata per histologisch type
- Schildklier neoplasmata
- Endocriene klierneoplasmata
- Hoofd- en nekneoplasmata
- Neoplasmata, glandulair en epitheel
- Adenocarcinoom
- Carcinoom
- Schildklier Ziekten
- Adenocarcinoom, Papillair
- Schildklierkanker, Papillair
- Adenocarcinoom, folliculair
- Onderzoekstechnieken
- Chemie -technieken, analytisch
- Spectrumanalyse
- Magnetische resonantiespectroscopie
Andere studie-ID-nummers
- 20-010573
- NCI-2022-03071 (Register-ID: CTRP (Clinical Trial Reporting Program))
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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