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Study to Evaluate the Effect of Age (Geriatric) and Kidney Function on the Safety, Efficacy and Pharmacokinetics of OctreoScan in Patients Who Have New or Recurrent Tumors

8. september 2016 oppdatert av: Mallinckrodt

An Open-Label, Multi-Center, Phase 4 Study to Evaluate the Effect of Age (Geriatric) and Renal Function on the Safety, Efficacy (Sensitivity, Specificity) and Pharmacokinetics of OctreoScan in Patients Referred for Scintigraphy of All Solid Tumors With a High Suspicion of Containing Somatostatin Receptor Positive Tissue

The objective of this study was to evaluate the effect of age (geriatric) and renal function on the safety, efficacy and pharmacokinetics of OctreoScan at the recommended clinical dose in this patient population.

Studieoversikt

Status

Avsluttet

Forhold

Studietype

Intervensjonell

Registrering (Faktiske)

150

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Florida
      • Miami, Florida, Forente stater, 33136
        • University of Miami, Jackson Memorial Hospital
    • Iowa
      • Iowa City, Iowa, Forente stater, 52242
        • University of Iowa Medical Center
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70112
        • Louisiana State University, Division of Hem/Onc
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Hospital of University of Pennsylvania, Division of Nuclear Medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Males or females 18 years of age and older.
  2. If female and of childbearing potential, patients must have a negative pregnancy test within 24 hours of study drug administration. In addition, all female patients of childbearing potential must agree to use a medically accepted method of contraception throughout the study.
  3. If deemed necessary by the Principal Investigator, patients entering the pharmacokinetic population must be willing to be housed within the investigational facility for a minimum of 24 hours following drug administration.
  4. Patients (when able) or legally authorized representatives must have the ability to understand the requirements of the study and provide written consent to participate and agree to abide by the study requirements.
  5. Patients must have tumor localization by conventional imaging methods prior to enrollment (i.e., CT, MRI, US, angiogram).
  6. Patients referred for scintigraphy of solid tumors with a high suspicion of containing somatostatin receptor positive tissue.
  7. Patients with first-time tumors must be scheduled for a tissue biopsy. A tissue sample will be sent to the core laboratory for conventional histology and immunohistochemistry analysis.
  8. Patients with recurrent tumors or progressive tumors must have previous biopsy results documented, with previous biopsy tissue obtainable for immunohistochemistry analysis.

Exclusion Criteria:

  1. Patients receiving Sandostatin LAR < 21 days prior to dosing or Sandostatin Immediate Release (IM) < 24 hours prior to dosing.
  2. Patients who have received any investigational drug within 30 days of admission into this study or plan to participate in a clinical study prior to the end of this study's monitoring period (patients on a research protocol using an approved drug are accepted).
  3. Patients who are pregnant, breastfeeding or lactating.
  4. Patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
  5. Patients scheduled to undergo any scintigraphy within 7 days prior to study participation or PET scanning within 24 hours prior to study participation.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Faktoriell oppgave
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Group 1
Control, age greater than or equal to 18 with normal renal function
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Andre navn:
  • OctreoScan
  • In-111
Eksperimentell: Group 2
Age 18 to less than 65 with mild renal impairment
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Andre navn:
  • OctreoScan
  • In-111
Eksperimentell: Group 3
Age 18 to less than 65 with moderate to severe renal impairment
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Andre navn:
  • OctreoScan
  • In-111
Eksperimentell: Group 4
Age 18 to less than 65 with end stage renal impairment
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Andre navn:
  • OctreoScan
  • In-111
Eksperimentell: Group 5
Age 65 to less than 75 with mild renal impairment
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Andre navn:
  • OctreoScan
  • In-111
Eksperimentell: Group 6
Age 65 to less than 75 with moderate to severe renal impairment
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Andre navn:
  • OctreoScan
  • In-111
Eksperimentell: Group 7
Age 65 to less than 75 with end stage renal impairment
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Andre navn:
  • OctreoScan
  • In-111
Eksperimentell: Group 8
Age greater than or equal to 75 with mild renal impairment
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Andre navn:
  • OctreoScan
  • In-111
Eksperimentell: Group 9
Age greater than or equal to 75 with moderate to severe renal impairment
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Andre navn:
  • OctreoScan
  • In-111
Eksperimentell: Group 10
Age greater than or equal to 75 with end stage renal impairment
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Andre navn:
  • OctreoScan
  • In-111

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive by biopsy with immunohistochemistry analysis
Tidsramme: Through 24 hours post dose
Through 24 hours post dose

Sekundære resultatmål

Resultatmål
Tidsramme
Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive using previously biopsied tissue for immunohistochemistry analysis
Tidsramme: Through 24 hours post dose
Through 24 hours post dose

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2003

Primær fullføring (Faktiske)

1. august 2005

Studiet fullført (Faktiske)

1. august 2005

Datoer for studieregistrering

Først innsendt

21. juli 2009

Først innsendt som oppfylte QC-kriteriene

22. juli 2009

Først lagt ut (Anslag)

23. juli 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. september 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. september 2016

Sist bekreftet

1. september 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 0050-02-763

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