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Review of Medical Records of Patients Who Have Been Treated With Lutetium at the Cross Cancer Institute Between January 2010 and July 31, 2012


N/A
14 Years
90 Years
Open (Enrolling)
Both
Neuroendocrine Tumors, NET

Thank you

Trial Information

Review of Medical Records of Patients Who Have Been Treated With Lutetium at the Cross Cancer Institute Between January 2010 and July 31, 2012


Neuroendocrine tumours comprise a spectrum of rare neoplasms. Data analysis will be
conducted to obtain efficacy, safety, and other relevant data from each Lu-177 DOTA-TATE
treatment.


Inclusion Criteria:



- Male or female ≥ 14 - 90 years of age

- Presence of histologically proven NET tumour(s)

- Serum creatinine ≤ 150 µmol/L, and a measured GFR using plasma clearance of ≥50
mL/min

- Haemoglobin concentration 5.5 mmol/L; WBC ≥ 2*109/L; platelets ≥ 100*109/L

- Liver function tests (serum albumin, total bilirubin, ALT, AST and alkaline
phosphatase) ≤ 3X the upper limit of normal

Exclusion Criteria:

- Potential for surgery with curative intent

- Surgery, radiation therapy, cytotoxic chemotherapy, embolization or other
investigative therapy (interferons, mTOR inhibitors) within 12 weeks of enrollment

- Known brain metastases unless these metastases have been treated and stabilized
(confirmed by CT) for ≥ 6 months prior to enrollment

- Uncontrolled congestive heart failure

- Receiving concomitant medications which decrease renal function

- Uncontrolled diabetes mellitus

- Pregnancy

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

Efficacy data on subjects with neuroendocrine tumours (NET) treated Lu-177 DOTA-TATE

Outcome Description:

Data (Radioisotope and CT/MRI images, blood assays and Quality of Life Questionnaires, pre and post treatment) will be collected to determine tumor response of subjects with NET after treatment with Lu-177 DOTA-TATE.

Outcome Time Frame:

Retrospective data January 2010 - July 2012

Safety Issue:

No

Principal Investigator

Alexander McEwan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services

Authority:

Canada: Health Canada

Study ID:

REV-LUT-001

NCT ID:

NCT01763554

Start Date:

October 2012

Completion Date:

December 2013

Related Keywords:

  • Neuroendocrine Tumors, NET
  • Lu-177
  • Lutetium-177
  • DOTA-TATE
  • Neuroendocrine tumors
  • radiopharmaceutical
  • Neuroendocrine Tumors

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