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Diagnostic Utility of [18F]-FDG-PET/CT and [124I]-PET/CT for Detection of Recurrence in Differentiated Thyroid Carcinoma

2011. június 15. frissítette: Korean Association of Endocrine Surgeons

Effectiveness of [124I]-PET/CT and [18F]-FDG-PET/CT for Localizing Recurrence in Patients With Differentiated Thyroid Carcinoma Who Have Elevated Serum Thyroglobulin Levels But Are Tumor-negative on Conventional Imaging Studies

Several studies have indicated that [124I]-PET/CT or [18F]-FDG-PET/CT may be useful to locate recurrent differentiated thyroid carcinoma lesions in patients with elevated thyroglobulin levels but who do not show pathological lesions when conventional imaging modalities are used. Thus, the investigators evaluated the effectiveness of PET/CT using both [124I] and [18F]-FDG in such patients.

A tanulmány áttekintése

Állapot

Ismeretlen

Részletes leírás

<Inclusion Criteria> Patients with histologically proven DTC were studied. All patients had previously undergone total thyroidectomy and more than one session of postoperative RI therapy. More than 12 months of follow-up after the last RI therapy session, all patients showed increasing pathological Tg levels (Tg > 9-10 ng/ml) after TSH stimulation (TSH > 30 mU/l). However, neither tumor recurrence nor metastasis could be detected in any patient by post-therapeutic [131I] scanning, neck US, or chest radiography. Patients with obvious cervical pathology or positive fine-needle aspiration cytology (FNAC) were excluded from the study. The work was approved by our Institutional Review Board and written informed consent was obtained from each patient.

<Study protocol> The study was prospectively designed to evaluate the diagnostic efficacies of [18F]-FDG-PET/CT and [124I]-PET/CT in patients with elevated Tg levels, but who yielded no pathological findings on conventional imaging. The [124I] radioisotope was supplied by the Radiopharmaceutical Research Team of the Korea Institute of Radiological and Medical Sciences (KIRAMS). All involved patients underwent a diagnostic [131I] scan, [18F]-FDG-PET/CT, and [124I]-PET/CT. On the first day (D1) of the study, blood and urine were collected for routine examination; to measure blood TSH, Tg, and anti-Tg antibody levels; and to assess urine iodine excretion after 4 weeks of levothyroxine (LT4) withdrawal. All patients had consumed a low-iodine diet for the prior 2 weeks, following written instructions and assisted by a dietician. On the second day (D2) of the study, an [131I] scan was obtained 48 h after administration of 74 MBq of [131I]. On day 10 (D10) of the study, patients fasted for at least 4 h before examination, and were (intravenously) given 370 MBq [18F]-FDG. All patients were instructed to rest comfortably for 60 min and to empty the bladder before scanning. Whole-body PET/CT images were obtained using a Discovery ST scanner (GE Healthcare, Milwaukee, WI). Seven or eight frames (3 min/frame) of emission PET data were acquired in the two-dimensional mode after noncontrast CT scans had been performed from the base of the skull to the upper thigh (tube rotation time of 1 s per revolution; 120 kV; 60 mA; 7.5 mm per rotation; and an acquisition time of 60.9 s for a scan length of 867 mm). Emission PET images were reconstructed via non-contrast CT using an iterative method (ordered-subsets expectation maximization with two iterations and 30 subsets; field of view 600 mm; slice thickness 3.27 mm). Attenuation-corrected PET/CT images were reviewed on an Xeleris workstation (GE Healthcare). All images were independently interpreted by two experienced nuclear medicine physicians and screened for "hot spots" indicative of hypermetabolic abnormalities.

On day 11 (D11) of the study, 24 h after administration of an [124I] trace dose (74 MBq), whole-body PET/CT scans were obtained using the Discovery ST scanner. First, a non-enhanced CT scan was performed, from the base of the skull to the upper thigh (tube rotation time of 1 s per revolution; 140 kV; 80 mA; 3.75 mm per rotation; acquisition time of 23.9 s for a scan length of 804 mm). Subsequently, seven or eight frames (5 min per frame) of emission PET data were acquired in the two-dimensional mode and reconstructed via CT using an iterative method (software from General Electric Medical Systems; ordered-subsets expectation maximization with two iterations and 21 subsets; field of view 600 mm; slice thickness 3.27 mm).

<Data analysis> To ensure that the interpretation of [18F]-FDG-PET/CT and [124I]-PET/CT data was performed under similar conditions, all physicians who initially read images of one type were deliberately blinded to the results of the other type of imaging, and to patient clinical data. This was achieved by ensuring that the interpreting physicians were not involved in patient clinical care. Findings on [18F]-FDG-PET and [124I]-PET scanning were compared with data from diagnostic and post-therapeutic [131I] scans. Moreover, the data were compared with those of radiological imaging (US, CT, and MRI information), and/or those of cytological investigation (FNAC), to confirm (or otherwise) the findings of the [131I] scans, and those of both forms of PET/CT (using [18F]-FDG and [124I]). For each patient, the presence or absence, and number and localization of any recurrent lesions (if present) were determined. The data of both types of PET/CT scans were classified as follows: 1) True-positive, if pathologic [18F]-FDG or [124I] uptake was proven by histology, cytology, or other imaging techniques, and caused therapy to be changed; 2) False-positive, if no pathologic [18F]-FDG or [124I] uptake was seen (such observations were of no clinical consequence); 3) True-negative, if no [18F]-FDG or [124I] uptake was found and the patient had neither an elevated Tg level nor any evidence of recurrence upon subsequent follow-up; and, 4) False-negative if no [18F]-FDG or [124I] uptake was noted despite elevated Tg levels, even if positive findings were obtained when other imaging methods were employed.

Tanulmány típusa

Megfigyelő

Beiratkozás (Várható)

50

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

15 év (Gyermek, Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

Study patients who underwent total thyroidectomy with more than one of high dose radioactive iodine treatment, showed elevated Tg levels, but who yielded no pathological findings on conventional imaging during follow-up period.

Leírás

Inclusion Criteria:

  • Study patients with histologically proven DTC were studied. All patients had previously undergone total thyroidectomy and more than one session of postoperative RI therapy.During follow-up after the last RI therapy session, all patients showed increasing pathological Tg levels (Tg > 9-10 ng/ml) after TSH stimulation (TSH > 30 mU/l). However, neither tumor recurrence nor metastasis could be detected in any patient by post-therapeutic [131I] scanning, neck US, or chest radiography.

Exclusion Criteria:

  • Patients with obvious cervical pathology or positive fine-needle aspiration cytology (FNAC) were excluded from the study. The work was approved by our Institutional Review Board and written informed consent was obtained from each patient.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Kohorszok és beavatkozások

Csoport / Kohorsz
Study patients
Study patients with histologically proven DTC were studied. All patients had previously undergone total thyroidectomy and more than one session of postoperative RI therapy. After the last RI therapy session, all patients showed increasing pathological Tg levels (Tg > 9-10 ng/ml) after TSH stimulation (TSH > 30 mU/l). However, neither tumor recurrence nor metastasis could be detected in any patient by post-therapeutic [131I] scanning, neck US, or chest radiography. Patients with obvious cervical pathology or positive fine-needle aspiration cytology (FNAC) were excluded from the study. The work was approved by our Institutional Review Board and written informed consent was obtained from each patient.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Diagnostic values of [124I]-PET/CT and [18F]-FDG-PET/CT imaging
Időkeret: Follow up in more than 10 months after treatment
1) True-positive, if pathologic [18F]-FDG or [124I] uptake(;PET-uptake) was proven by histology, cytology, or other imaging techniques, and caused therapy to be changed; 2) False-positive, if no pathologic PET-uptake was seen; 3) True-negative, if no PET-uptake was found and the patient had neither an elevated Tg level nor any evidence of recurrence upon subsequent follow-up; and, 4) False-negative if no PET-uptake was noted despite elevated Tg levels, even if positive findings were obtained when other imaging methods were employed.
Follow up in more than 10 months after treatment

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Nyomozók

  • Kutatásvezető: Jandee Lee, MD, Korean Association of Endocrine Surgeons

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2009. július 1.

Elsődleges befejezés (Tényleges)

2011. június 1.

A tanulmány befejezése (Várható)

2012. augusztus 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2011. június 15.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2011. június 15.

Első közzététel (Becslés)

2011. június 16.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Becslés)

2011. június 16.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2011. június 15.

Utolsó ellenőrzés

2011. január 1.

Több információ

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

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