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Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors

StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Primary completion date changed from estimate of Jun 2026 to Aug 18, 2026 · Eligibility criteria expanded, about 36 words · Publications: details revised at 1 of 1 entry Show 3 more changesShow less
    • Primary completion date changed from estimate of Jun 2026 to Aug 18, 2026
    • Eligibility criteria expanded, about 36 words
    • Publications: details revised at 1 of 1 entry
  2. 3 versions Re-verified since Jul 24, 2023, no change to tracked fieldsv10-v12
  3. Primary and study completion dates: Jan 2024 to Jun 2026 Trial status: Recruiting to Active, Not Recruiting · Start date: Jul 2016 to Jul 15, 2016 · Site details revised at 4 of 4 sitesv9 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Start date: Jul 2016 to Jul 15, 2016
    • Site details revised at 4 of 4 sites
  4. 3 versions Re-verified since Mar 25, 2019, no change to tracked fieldsv6-v8
  5. Eligibility criteria shortened, about 17 wordsv5 See this version in full on ClinicalTrials.gov ↗
Show 3 earlier versionsHide 3 earlier versions
  1. Eligibility criteria expanded, about 69 wordsv4 See this version in full on ClinicalTrials.gov ↗
  2. Trial status: Not Yet Recruiting to Recruiting Site details revised at 4 of 4 sitesv3 Show 1 more changeShow less
    • Site details revised at 4 of 4 sites
  3. Study sites revised (4) Collaborators: 2 to 3v2 Show 1 more changeShow less
    • Collaborators: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a prospective single arm, multicenter study will evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has progressed with neuroendocrine tumor will be evaluated by the tumor board first and eligible patients will undergo diagnostic Ga 68 PET scan. Patients who showed Somatostatin will undergo 4 cycles of Lu-DOTATATE treatment. Dose adjustment for Cycle 2-4 will be made based on individualized dosimetry, as well as creatinine clearance and hematological parameters. Patients will be evaluated progression free survival at 12 months from last dose. Patients who are negative for somatostatin will not receive 68Ga-DOTATATE treatment but will be followed until progression and acts as control group.
Trial Details
NCT Number NCT02743741
Lead Sponsor University Health Network, Toronto
Collaborators: Ozmosis Research Inc., Cancer Care Ontario, Canadian Molecular Imaging Probe Consortium
Conditions Neuroendocrine Tumors
Enrollment 195 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov