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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 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Studietyp

Interventionell

Inskrivning (Faktisk)

150

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Faktoriell uppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Andra namn:
  • OctreoScan
  • In-111
Experimentell: Group 2
Age 18 to less than 65 with mild renal impairment
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Andra namn:
  • OctreoScan
  • In-111
Experimentell: 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
Andra namn:
  • OctreoScan
  • In-111
Experimentell: 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
Andra namn:
  • OctreoScan
  • In-111
Experimentell: Group 5
Age 65 to less than 75 with mild renal impairment
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Andra namn:
  • OctreoScan
  • In-111
Experimentell: 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
Andra namn:
  • OctreoScan
  • In-111
Experimentell: 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
Andra namn:
  • OctreoScan
  • In-111
Experimentell: 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
Andra namn:
  • OctreoScan
  • In-111
Experimentell: 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
Andra namn:
  • OctreoScan
  • In-111
Experimentell: 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
Andra namn:
  • OctreoScan
  • In-111

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2003

Primärt slutförande (Faktisk)

1 augusti 2005

Avslutad studie (Faktisk)

1 augusti 2005

Studieregistreringsdatum

Först inskickad

21 juli 2009

Först inskickad som uppfyllde QC-kriterierna

22 juli 2009

Första postat (Uppskatta)

23 juli 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

9 september 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 september 2016

Senast verifierad

1 september 2016

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 0050-02-763

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