Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors

NCT01619865 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: 201110718114398
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

Brief Summary

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. Goals are to 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), this scan will be used to 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.

Conditions

Neuroendocrine Tumors; Carcinoid Tumors; Neuroblastoma; Medulloblastoma

Keywords

GA-68; Gallium 68; GA-68 PET

Outcome Measures

Primary Outcomes (2)

• To Measure Safety of 68Ga-DOTATOC Positron Emission Tomography (PET) by Measuring the Number of Adverse Events Related to the Investigational Radiopharmaceutical Agent

  Subject receives an injection of 68Ga-DOTATOC, a somatostatin-like peptide that binds to somatostatin receptor and is tagged with a radionuclide that can be detected by positron emission tomography (PET). Whole body PET is performed; patient is queried regarding any adverse events immediately and again 24 hrs after completion of scan read by certified nuclear medicine physician to determine if any known tumor lesions take up 68Ga-DOTATOC.Severity of adverse events will be graded according to NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). Adverse events are assessed immediately after PET scan and 24 hrs after completion of the scan.

  During PET scan and 24 hours post scan

• Number of Subjects With Adverse Events Related to the Use of the 68Ga-DOTATOC

  Number of subjects with adverse events related to the use of the 68Ga-DOTATOC radiopharmaceutical in accordance with National Cancer Institute (NCI) toxicity guidelines (NCI Common Terminology Criteria for Adverse Events version 4.0)

  Up to 6 months

Study Arms (1)

68Ga-DOTATOC PET/CT

EXPERIMENTAL

68Ga-DOTATOC Positron Emission Tomography (PET) for Diagnosis, Staging, and Measurement of Response to Treatment in Somatostatin Receptor Positive Tumors

Drug: 68Ga-DOTATOC PET/CT

Interventions

68Ga-DOTATOC PET/CT DRUG

1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV.

Also known as: Gallium 68-DOTATOC

68Ga-DOTATOC PET/CT

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Age greater than or equal to 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)
• Subject is male; or is a female who is either pre-menarchal, surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (\> 1 years without menses), non-lactating, or of childbearing potential for whom a serum pregnancy test (with the results known prior to investigational product administration) is negative. A negative serum pregnancy test will be required for all female subjects with child bearing potential. If a false pregnancy test is suspected, e.g., perimenopausal condition, an obstetrician will be consulted to determine if she is/is capable of becoming pregnant.

You may not qualify if:

• Subject weighs more than 400 pounds (Subjects who weigh more than 400 pounds will not be able to fit inside the imaging machines).
• 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.)
• Does the subject have any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance?

Sponsors & Collaborators

• Sue O'Dorisio: lead

Study Sites (1)

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

• Abongwa C, Mott S, Schafer B, McNeely P, Abusin G, O'Dorisio T, Zamba G, O'Dorisio MS, Menda Y. Safety and accuracy of 68Ga-DOTATOC PET/CT in children and young adults with solid tumors. Am J Nucl Med Mol Imaging. 2017 Nov 1;7(5):228-235. eCollection 2017.

  PMID: 29181270 RESULT

• Menda Y, O'Dorisio TM, Howe JR, Schultz M, Dillon JS, Dick D, Watkins GL, Ginader T, Bushnell DL, Sunderland JJ, Zamba GKD, Graham M, O'Dorisio MS. Localization of Unknown Primary Site with 68Ga-DOTATOC PET/CT in Patients with Metastatic Neuroendocrine Tumor. J Nucl Med. 2017 Jul;58(7):1054-1057. doi: 10.2967/jnumed.116.180984. Epub 2017 Feb 2.

  PMID: 28153957 RESULT

MeSH Terms

Conditions

Neuroendocrine Tumors; Carcinoid Tumor; Neuroblastoma; Medulloblastoma

Interventions

gallium Ga 68 dotatate

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Glioma

Results Point of Contact

• Title: Sue O'Dorisio, MD, PhD
• Organization: University of Iowa Holden Comprehensive Cancer Center

sue-odorisio@uiowa.edu

319-356-7873

Study Officials

• Sue O'Dorisio, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: The Octreoscan and 68Ga-DOTA-tyr3-Octreotide PET scans are read independently by two certified nuclear medicine physicians for discordant positive lesions.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 14, 2012
• Study Start: February 21, 2012
• Primary Completion: August 27, 2017
• Study Completion: August 27, 2017
• Last Updated: July 27, 2021
• Results First Posted: February 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Results are shared when clinically available.
• Access Criteria: Results are placed in patient's electronic medical record.

Locations

US (1)