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Monitor Response to Treatment in Neuroblastoma Using 3&Apos;-Deoxy-3&Apos;-Fluorothymidine- Positron Emission Tomography (FLT-PET)

4. april 2017 opdateret af: Zhihong Wang, Barbara Ann Karmanos Cancer Institute

Pilot Study to Determine the Utility of [18F] 3&Apos;-Deoxy-3&Apos;-Fluorothymidine- Positron Emission Tomography in Monitoring Patient Response to Chemotherapy in Neuroblastoma

The purpose of this study is to gain knowledge about how to best diagnose and treat tumors, how tumors affect normal tissue and how treatment of tumors with radiation therapy and chemotherapy affect tumors.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The purpose of this research study is to observe the changes within the tumor cells which may improve the understanding of how tumors grow and how they respond to various treatments. These changes will be compared with results of the physical examination and scans (CT and MRI) that are done as part of clinical care. Images will be made showing the distribution throughout the body of substances containing a small amount of radioactive material. This procedure is called a PET scan. The radioactive substances (tracer compound) in this study are [F-18] FLT.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Rekruttering
        • Children's Hospital of Michigan
        • Kontakt:
          • Zhihong J Wang, M.D., Ph.D.
          • Telefonnummer: 313-577-5515
        • Kontakt:
          • Anthony F Shields, M.D., Ph.D.
          • Telefonnummer: (313) 576-8735
        • Underforsker:
          • Majid Khalaf, M.D.
        • Underforsker:
          • Yaddanapudi Ravindranath, M.D.
        • Underforsker:
          • Diane Chugani, Ph.D.
        • Underforsker:
          • Jeffrey Taub, M.D.
        • Underforsker:
          • Sureyya Savasan, M.D.
        • Underforsker:
          • Roland Chu, M.D.
        • Underforsker:
          • Kanta Bhambhani, M.D.
        • Underforsker:
          • Anthony F Shields, M.D., Ph.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 dag til 21 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • All patients with neuroblastoma or suspected neuroblastoma seen at Children's Hospital of Michigan (CHM). Patients need to be 2 years or older to be eligible for the initial study
  • Patients must be 1 day to 21 years old, there is no gender limit.
  • Diagnosis: All patients with neuroblastoma or suspected neuroblastoma, including newly diagnosed and relapsed patients, are eligible for Objective 1. To be eligible for Objective 2, patients must have a diagnosis of neuroblastoma verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites, and have measurable disease after the initial surgery
  • Female adolescent patients must have a negative pregnancy test within 14 days of first imaging and should not be pregnant
  • Patients must be able to lie still for the tests, or have no contraindication for sedation
  • Patients or their legal guardian must sign an informed consent indicating that they are aware of the investigational nature of this study
  • A total number of 40-50 patients will be included in the study

Exclusion Criteria:

  • Patients who do not have a histology diagnosis of neuroblastoma are not eligible for the study
  • Patients whose definite diagnosis after surgery is not consistent with the diagnosis of neuroblastoma will be included in the Objective 1 but excluded for Objective 2.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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: FLT-PET

Patients will be managed per COG protocol ANBL00B1 (low risk, LR), ANBL0521 (intermediate risk, IR), ANBL0531 (high risk, HR) or other future neuroblastoma studies according to their risk group (risk assignment, treatment schema and protocols are available in COG website). The following is a brief description of the treatment.

  1. Low risk patients: observation only.
  2. Intermediate risk patients: chemotherapy stratified according to risk sub-groups followed by surgical resection.
  3. High risk patients: 6 courses of induction chemotherapy, surgical resection and high dose chemotherapy with autologous stem cell transplant (SCT), involved field radiation and 6 months of Isotrenitoin.

PET scan will be conducted at diagnosis, at the end of the first cycle of treatment and prior to the surgical procedure (resection).
Enhed: FLT-PET
PET scan will be conducted at diagnosis, at the end of the first cycle of treatment and prior to the surgical procedure (resection).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
To determine whether 18F-FLT-PET is a sensitive tool to image neuroblastoma.
Tidsramme: 1st PET - At diagnosis
1st PET - At diagnosis

Sekundære resultatmål

Resultatmål
Tidsramme
To evaluate the utility of FLT-PET in early assessment of patient response to treatment.
Tidsramme: 1st PET - At diagnosis
1st PET - At diagnosis
To evaluate the utility of FLT-PET in early assessment of patient response to
Tidsramme: 2nd PET - Approx. 3 wks (end of 1st cycle)
2nd PET - Approx. 3 wks (end of 1st cycle)
To evaluate the utility of FLT-PET in early assessment of patient response to treatment.
Tidsramme: 3rd PET: 6-15 wks (Prior to surgery)
3rd PET: 6-15 wks (Prior to surgery)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Barbara Ann Karmanos Cancer Institute

Samarbejdspartnere

Children's Hospital of Michigan

Efterforskere

  • Ledende efterforsker: Anthony F. Shields, M.D., Ph.D., Barbara Ann Karmanos Cancer Institute

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2011

Primær færdiggørelse (Forventet)

1. februar 2018

Studieafslutning (Forventet)

1. februar 2018

Datoer for studieregistrering

Først indsendt

22. februar 2011

Først indsendt, der opfyldte QC-kriterier

3. marts 2011

Først opslået (Skøn)

4. marts 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • WSU 2009-031

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 .

Kliniske forsøg med Neuroblastom

Kliniske forsøg med FLT-PET

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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