- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00416949
Iodine I 131 in Treating Patients With Thyroid Cancer
Dose-Response in Radionuclide Therapy of Thyroid Cancer
RATIONALE: Radioactive iodine kills thyroid cancer cells by giving off radiation.
PURPOSE: This clinical trial is studying the side effects, best dose, and how well iodine I 131 works in treating patients with thyroid cancer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- Determine the relationship between estimated absorbed dose of iodine I 131 and tumor response or normal organ toxicity for different dosimetric measures, using data derived from clinical radionuclide therapy studies in patients with thyroid cancer.
OUTLINE: Patients receive oral dosimetric iodine I 131 (^131I) on day 2 and then undergo nuclear medicine imaging at 0.5-4 hours, 24, 48, and 72 hours after dosimetric ^131I. Single-photon emission computed tomography (SPECT)/CT scans are performed at 0.5-4 hours and 24 or 48 hours over the head and neck region, including the salivary glands. Subsequent SPECT/CT scans are performed over the candidate tumor sites. Patients undergo ^131I therapy on day 11.
Saliva is collected on days 1 and 2, weeks 2 and 4, and months 3 and 6 to measure saliva flow rate. Blood is collected at baseline and periodically during study to measure FLT3 ligand levels.
PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
- Diagnosis of thyroid cancer
- Measurable disease by CT scan or nuclear medicine imaging
- Eligible, by standard of care criteria, for iodine I 131 therapy
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective non-barrier method contraception (e.g., combined or progesterone-only oral contraceptive pill, intrauterine device, depot progesterone, or stable relationship with a partner who has had a vasectomy)
- No other malignancy within the past 5 years except squamous cell or basal cell carcinoma of the skin
- No nonthyroidal conditions known to affect iodine I 131 uptake (e.g., New York Heart Association class III or IV congestive heart failure or renal failure)
- No alcoholism or drug abuse within the past 2 years
- No severe emotional, behavioral, or psychiatric problems that would preclude study compliance (e.g., severe claustrophobia)
PRIOR CONCURRENT THERAPY:
- No intravenous water-soluble radiographic contrast within the past 4 weeks
- No iodinated contrast agent within the past 3 months
- No concurrent drugs that may affect thyroid or renal function (e.g., renal drugs, lithium, amiodarone, other iodine-containing medication, or corticosteroids)
- No other concurrent investigational drugs
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Patient-specific 3D-RD Dosimetry
Applied a patient-specific dosimetry calculation method to the imaging data collected to calculate tumor absorbed doses, using 3D-RD method.
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Patient-specific 3D-RD dosimetry was applied to the data collected
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Tumor Absorbed Dose
Tidsramme: up to 4 years
|
Tumor absorbed doses (Gy) calculated using patient-specific dosimetry.
|
up to 4 years
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: George Sgouros, PhD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- anaplastisk kræft i skjoldbruskkirtlen
- skjoldbruskkirtel medullært karcinom
- tilbagevendende kræft i skjoldbruskkirtlen
- insulær skjoldbruskkirtelkræft
- fase II follikulær skjoldbruskkirtelkræft
- stadium II papillær skjoldbruskkirtelkræft
- fase I follikulær skjoldbruskkirtelkræft
- stadium I papillær skjoldbruskkirtelkræft
- stadium III follikulær skjoldbruskkirtelkræft
- stadium III papillær skjoldbruskkirtelkræft
- stage IVA follicular thyroid cancer
- stage IVB follicular thyroid cancer
- stage IVC follicular thyroid cancer
- stage IVA papillary thyroid cancer
- stage IVB papillary thyroid cancer
- stage IVC papillary thyroid cancer
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- J0628
- CDR0000522716 (Registry Identifier: PDQ (Physician Data Query))
- R01CA116477-01A1 (NIH)
- NA_00002264 (Anden identifikator: JHM IRB)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret enhedsprodukt
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