- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01839747
Evaluation of PET/MRI in Children With Cancer
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
If you agree to participate in this study you will be asked to fill out a screening questionnaire to determine if you can participate. No additional screening tests or procedures will be necessary prior to your participation in this study.
If the screening questionnaire shows that you are eligible to participate in the research study, you will be scheduled to undergo your PET/MRI in conjunction with your PET/CT. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
After th screening procedures confirm that you are eligible to participate in the research study:
- You will schedule your PET/CT examination with the MGH radiology department according to the orders and instructions of your oncologist (cancer doctor)
- Study personnel will coordinate the scheduling of your PET/MRI examination to coincide with date and time of your PET/CT examination
- Following the performance of your PET/CT examination you will be transported (with your accompanying family member(s)) to the Charlestown Navy Yard MGH imaging facility where you will undergo your PET/MRI examination. No additional dose of radioactive tracer (a substance which is labeled with a radioactive molecule that can be tracked within your body based on the radiation it emits) will be given as part of your PET/MRI examination
- The PET/MRI will take up to 60 minutes to complete and after it is completed you will be free to go
- The PET/MRI images will be interpreted by physicians (trained radiologists) as part of the study analysis; however no report of the findings will be made available to you. You will have access to the results of the PET/CT examination as you would any other clinical imaging examination.
- If you are willing, with each subsequent PET/CT examination you undergo while enrolled in the study, you will also undergo a PET/MRI examination
- The study will last for 12 months, after which time you will no longer be enrolled
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Michael Gee, MD, PhD
- Telefonnummer: 6177244207
- E-mail: msgee@partners.org
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02114
- Rekruttering
- Massachusetts General Hospital
-
Kontakt:
- Michael Gee, MD, PhD
- Telefonnummer: 617-724-4207
- E-mail: msgee@partners.org
-
Ledende efterforsker:
- Michael Gee, MD, PhD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Able to lie comfortably on a bed inside the scanner for 60 minutes as assessed by physical examination and medical history
Exclusion Criteria:
- Requirement for sedation or anesthesia of any kind in order to undergo MRI scanning
- Electrical implants such as cardiac pacemakers or perfusion pumps
- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing
- Pregnancy or breastfeeding
- Pre-existing medical conditions or claustrophobic reactions, and any greater than normal potential for cardiac arrest
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Imaging
PET-MRI PET-CT
|
Imaging
Imaging
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Comparison of Imaging Quality between PET-MRI and PET-CT
Tidsramme: 2 years
|
To perform a qualitative comparison of image quality between PET-MRI and PET-CT exams being performed on pediatric oncology patients during the same visit
|
2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Comparison of PET-MRI SUV Values and PET-CT FDG Reference
Tidsramme: 2 years
|
To compare the ability of PET-MRI to determine the extent of active malignancy by comparing PET-MRI SUV values with PET-CT FDG reference
|
2 years
|
Assessment of Unexpected Indeterminate Lesions
Tidsramme: 2 years
|
To assess the number of unexpected indeterminate lesions detected on PET-MRI and PET-CT studies requiring additional workup
|
2 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Michael Gee, MD, PhD, Massachusetts General Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 12-307
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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