Safety and Efficacy of 68Ga-DOTA-tyr3-Octreotide (GA-68)
This study is currently recruiting participants.
Verified June 2012 by University of Iowa
Sponsor:
University of Iowa
Information provided by (Responsible Party):
O'Dorisio, M S, University of Iowa
ClinicalTrials.gov Identifier:
NCT01619865
First received: June 12, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
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Purpose
This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging, and measurement of response to treatment in patients with somatostatin receptor positive tumors. We will 1) compare this unique PET/CT scan with the current standard of care which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those patients who have had recent treatment (e.g., surgery, chemotherapy, targeted therapy such as anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), we will measure response to treatment. These studies will be obtained with the long term goal of submitting a New Drug Application (NDA) for FDA approval of 68Ga-DOTATOC PET/CT in adults and children.
| Condition | Intervention |
|---|---|
|
Neuroendocrine Tumors Carcinoid Tumors Neuroblastoma Medulloblastoma |
Drug: 68Ga-DOTATOC PET/C |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Safety and Efficacy of 68Ga-DOTA-tyr3-Octreotide PET/CT in Diagnosis, Staging and Measurement of Response to Treatment in Patients With Somatostatin Receptor Positive Tumors: Comparison to Octreoscan Plus High-Resolution, Contrast Enhanced CT. |
Resource links provided by NLM:
Further study details as provided by University of Iowa:
Primary Outcome Measures:
- This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging, and measurement of response to treatment in patients with somatostatin receptor positive tumors. [ Time Frame: 1 week to 6 months ] [ Designated as safety issue: Yes ]We will 1) compare this unique PET/CT scan with the current standard of care which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those patients who have had recent treatment after the initial PET/CT scan (e.g., surgery, chemotherapy, targeted therapy such as anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), we will measure response to treatment.
| Estimated Enrollment: | 200 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: 68Ga-DOTATOC PET/C
1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV.
Other Name: Gallium 68
Show Detailed Description Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Signed informed consent
- Age greater than 2 years
- Known or suspected somatostatin receptor positive tumor such as carcinoid; neuroendocrine tumor; neuroblastoma; medulloblastoma; pheochromocytoma. Supporting evidence may include MRI, CT, biochemical markers, and or pathology report.
- Karnofsky performance status or Lansky Play Scale status of greater than 50 (or ECOG/WHO equivalent)
- Not pregnant. A negative serum pregnancy test will be required for all female subjects with child bearing potential.
Exclusion Criteria:
Inclusion Criteria:
- Signed informed consent
- Age greater than 2 years
- Known or suspected somatostatin receptor positive tumor such as carcinoid; neuroendocrine tumor; neuroblastoma; medulloblastoma; pheochromocytoma. Supporting evidence may include MRI, CT, biochemical markers, and or pathology report.
- Karnofsky performance status or Lansky Play Scale staus of greater than 50 (or ECOG/WHO equivalent)
- Not pregnant. A negative serum pregnancy test will be required for all female subjects with child bearing potential.
Exclusion Criteria
- Pregnant or lactating women
- Patients with a body weight of 400 pounds due to weight limitations of the scanner or are not able to enter the bore of the PET/CT scanner due to BMI
- Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.)
- Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619865
Contacts
| Contact: Sue O'Dorisio, MD | 319-356-3595 | sue-odorisio@uiowa.edu |
| Contact: Suzanne R Kieffer | 319-530-8051 | suzanne-kieffer@uiowa.edu |
Locations
| United States, Iowa | |
| University of Iowa Health Care | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Suzanne R Kieffer 319-530-8051 suzanne-kieffer@uiowa.edu | |
| Contact: Sue O'Dorisio, MD 319-356-3595 sue-odorisio@uiowa.edu | |
| Principal Investigator: Sue O'Dorisio, MD | |
| Principal Investigator: Thomas M O'Dorisio, MD | |
Sponsors and Collaborators
University of Iowa
Investigators
| Principal Investigator: | Sue O'Dorisio, MD | University of Iowa Health Care |
More Information
No publications provided
| Responsible Party: | O'Dorisio, M S, Professor of Medicine, University of Iowa |
| ClinicalTrials.gov Identifier: | NCT01619865 History of Changes |
| Other Study ID Numbers: | 201110718, 114398 |
| Study First Received: | June 12, 2012 |
| Last Updated: | June 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Iowa:
|
GA-68 Gallium 68 GA-68 PET |
Additional relevant MeSH terms:
|
Carcinoid Tumor Medulloblastoma Neuroblastoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Octreotide Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 19, 2013