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
NCT ID: NCT00944372
Last Updated: 2016-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE4
150 participants
INTERVENTIONAL
2003-07-31
2005-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas
NCT02503423
Study of the Safety, Tolerability and Efficacy of KPT-8602 in Participants With Relapsed/Refractory Cancer Indications
NCT02649790
Safety, Tolerability and Pharmacokinetics of DCBCI0901 in Patients With Advanced Solid Tumor
NCT02151357
L-778,123 in Treating Patients With Recurrent or Refractory Solid Tumors
NCT00003430
Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors
NCT02048709
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
FACTORIAL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Control, age greater than or equal to 18 with normal renal function
Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Group 2
Age 18 to less than 65 with mild renal impairment
Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Group 3
Age 18 to less than 65 with moderate to severe renal impairment
Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Group 4
Age 18 to less than 65 with end stage renal impairment
Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Group 5
Age 65 to less than 75 with mild renal impairment
Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Group 6
Age 65 to less than 75 with moderate to severe renal impairment
Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Group 7
Age 65 to less than 75 with end stage renal impairment
Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Group 8
Age greater than or equal to 75 with mild renal impairment
Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Group 9
Age greater than or equal to 75 with moderate to severe renal impairment
Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Group 10
Age greater than or equal to 75 with end stage renal impairment
Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mallinckrodt
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mallinckrodt
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Miami, Jackson Memorial Hospital
Miami, Florida, United States
University of Iowa Medical Center
Iowa City, Iowa, United States
Louisiana State University, Division of Hem/Onc
New Orleans, Louisiana, United States
Hospital of University of Pennsylvania, Division of Nuclear Medicine
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0050-02-763
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.