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Combination Targeted Radiotherapy in Neuroendocrine Tumors


N/A
18 Years
N/A
Open (Enrolling by invite only)
Both
Neuroendocrine Tumors

Thank you

Trial Information

Combination Targeted Radiotherapy in Neuroendocrine Tumors


Inclusion Criteria:



- Subjects with biopsy-proven metastatic (soft tissue) neuroendocrine tumors.

- Subjects with a Southwest Oncology Group (SWOG) performance score of 0-2 and an
expected median survival of at least 6 months.

- The subject is able and willing to comply with study procedures and a signed and
dated informed consent is obtained.

- Subjects must be >18 years of age

Exclusion Criteria:

- Subjects who use medications that are known to interfere with MIBG uptake and is
unable to discontinue for medical reasons.

- Prior chemotherapy, radiotherapy or any investigational drugs within 60 days prior
admission into this study. Patients must have recovered from all therapy-related
toxicities

- Renal insufficiency with a serum creatinine > 2mg/dl.

- Subjects unable to lie still for the imaging studies.

- Subjects who because of their weight and body distribution do not fit into the
imaging machine.

- Subjects receiving Sandostatin LAR < 21 days prior to dosing or Sandostatin Immediate
Release (IR) < 24 hours prior to dosing.

- Female patients who are pregnant or breast feeding. Women of childbearing potential
must have a negative serum/urine pregnancy test within 48 hours prior to
administration of study treatment.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Dosimetry Results

Outcome Description:

Determine the patient specific bone marrow, kidney and tumor dosimetry results for each subject from the 2 groups will be used to calculate the optimal combination of administered activities for 131I-MIBG plus 90Y-DOTATOC (group 1) 131I-MIBG plus 177Lu-DOTATATE (group 2) and the resultant dose delivery to tumor from each combination

Outcome Time Frame:

1 week after scan

Safety Issue:

No

Principal Investigator

David Bushnell, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Iowa; Veteran Affairs

Authority:

United States: Federal Government

Study ID:

200602763

NCT ID:

NCT01099228

Start Date:

March 2007

Completion Date:

December 2013

Related Keywords:

  • Neuroendocrine Tumors
  • Neuroendocrine Tumor
  • Imaging
  • Neuroendocrine Tumors

Name

Location

University of IowaIowa City, Iowa  52242
Department of Veteran Affairs Medical CenterIowa City, Iowa  52246