Évaluation du 18F-TFB PET/CT Scan chez les patients atteints d'un cancer différencié de la thyroïde
Évaluation de la TEP/TDM au tétrafluoroborate de F-18 (18F-TFB) chez les patients atteints d'un cancer différencié de la thyroïde
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
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Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic in Rochester
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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
Autres noms:
Given IV
Autres noms:
Undergo a PET/CT scan
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Descriptive summaries of detected lesions
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
True positive and negative lesions
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Stephen M. Broski, M.D., Mayo Clinic in Rochester
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système endocrinien
- Tumeurs par site
- Tumeurs
- Tumeurs par type histologique
- Tumeurs thyroïdiennes
- Tumeurs des glandes endocrines
- Tumeurs de la tête et du cou
- Tumeurs, glandulaires et épithéliales
- Adénocarcinome
- Carcinome
- Maladies thyroïdiennes
- Adénocarcinome papillaire
- Cancer de la thyroïde, papillaire
- Adénocarcinome folliculaire
- Techniques d'investigation
- Techniques de chimie, analytique
- Analyse du spectre
- Spectroscopie de résonance magnétique
Autres numéros d'identification d'étude
- 20-010573
- NCI-2022-03071 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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