NCT01099228

Brief Summary

The primary aim of this project is to determine, what fraction of individuals with neuroendocrine tumors would show substantially improved tumor dosimetry with combined agent therapy compared to "best" single agent therapy and determine the magnitude of the potential tumor radiation dose increase.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 6, 2010

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 21, 2016

Status Verified

July 1, 2016

Enrollment Period

1.6 years

First QC Date

March 26, 2010

Last Update Submit

July 19, 2016

Conditions

Neuroendocrine Tumors

Keywords

Neuroendocrine TumorImaging

Outcome Measures

Primary Outcomes (1)

  • Dosimetry Results

    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

    1 week after scan

Secondary Outcomes (1)

  • Maximum Radiation Dose

    3 months

Study Arms (2)

131-I MIBG and 111I-n pentetreotide

ACTIVE COMPARATOR

131-I MIBG and 111I-n pentetreotide

Other: 131-I MIBG and 111-In pentetreotide

131-I MIBG and In-111 DOTATATE

ACTIVE COMPARATOR

131-I MIBG and In-111 DOTATATE

Other: 131-I MIBG and In-111 DOTATATE

Interventions

131-I MIBG and 111-In pentetreotideOTHER

Subjects will receive 131I MIBG and 111In pentetreotide(surrogate for Y90-DOTATOC)

131-I MIBG and 111I-n pentetreotide
131-I MIBG and In-111 DOTATATEOTHER

131I MIBG and In-111 DOTATATE (surrogate for 177Lu DOTATATE)

131-I MIBG and In-111 DOTATATE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 2 X ULN
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Department of Veteran Affairs Medical Center

Iowa City, Iowa, 52246, United States

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

3-Iodobenzylguanidinepentetreotide

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsIodobenzenesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsHydrocarbons, IodinatedHydrocarbons, Halogenated

Study Officials

  • David Bushnell, M.D.

    University of Iowa; Veteran Affairs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Radiology

Study Record Dates

First Submitted

March 26, 2010

First Posted

April 6, 2010

Study Start

September 1, 2006

Primary Completion

April 1, 2008

Study Completion

July 1, 2015

Last Updated

July 21, 2016

Record last verified: 2016-07

Locations

US(2)