Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors

NCT02441062 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 201503708
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

Participants in this study have been diagnosed with a tumor such as a carcinoid, neuroendocrine tumor, neuroblastoma, Ewing's sarcoma, or brain tumor that has cells which carry somatostatin receptors. The purpose of this research study is to see if the tumor can be identified using a special procedure called a positron emission tomography (PET) scan and how the results of this imaging procedure will change the management of the tumor.

Conditions

Neuroendocrine Tumors; Carcinoid Tumors; Neuroblastoma; Medulloblastoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Change in Treatment Management Based on Findings of the Gallium Ga 68-edotreotide PET/CT Scan

  Referring physicians will be asked to fill out pre-PET and post-PET scan forms to provide information on the management and treatment strategy of the patient before the PET-CT scan and after the information from the PET-CT study is available. This is the same methodology used in the National Oncologic PET Registry study; change in management strategy criteria are modified for the specific treatment strategies used in NET.

  36 months

Study Arms (1)

68Ga-DOTATOC PET/CT

OTHER

Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Subjects may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.

Drug: 68Ga-DOTATOC PET/CT

Interventions

68Ga-DOTATOC PET/CT DRUG

Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors

68Ga-DOTATOC PET/CT

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Age ≥ 6 months
• Histologically diagnosed neuroendocrine tumor or other tumor with probable somatostatin receptors subtype 2
• Karnofsky performance status or Lansky Play Scale status of ≥ 60 (or ECOG/WHO equivalent)
• Subject is male; or is a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (\> 1 years without menses), ≥60 years old,or of childbearing potential for whom a pregnancy test (with the results known prior to investigational product administration) is negative. A negative 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 not capable of becoming pregnant. Female must also be non-lactating.

You may not qualify if:

• Subject weighs more than 450 pounds. (Subjects who weigh more than 450 pounds will not be able to fit inside the imaging machines) or otherwise cannot be safely fit into the imaging system.
• Inability to lie still for the entire imaging time (due to 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.
• Peptide receptor radionuclide therapy (PRRT) within 4 weeks of Ga-68 DOTATOC PET/CT scan.
• Treatment with Sandostatin LAR within 4 weeks, SQ Octreotide within 12 hours, or Lanreotide injection within 8 weeks of Ga-68 DOTATOC PET/CT (+/-5%).

Sponsors & Collaborators

• Sue O'Dorisio: lead
• University of Iowa: collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• Menda Y, Ponto LL, Schultz MK, Zamba GK, Watkins GL, Bushnell DL, Madsen MT, Sunderland JJ, Graham MM, O'Dorisio TM, O'Dorisio MS. Repeatability of gallium-68 DOTATOC positron emission tomographic imaging in neuroendocrine tumors. Pancreas. 2013 Aug;42(6):937-43. doi: 10.1097/MPA.0b013e318287ce21.

  PMID: 23587853 BACKGROUND

MeSH Terms

Conditions

Neuroendocrine Tumors; Carcinoid Tumor; Neuroblastoma; Medulloblastoma

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: M.Sue O'Dorisio
• Organization: University of Iowa, Holden Comprehensive Cancer Center

sue-odorisio@uiowa.edu

(319) 335-7234

Study Officials

• Mary S O'Dorisio, MD, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Pediatrics Hematology/Oncology

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 12, 2015
• Study Start: September 1, 2015
• Primary Completion: January 20, 2020
• Study Completion: January 20, 2020
• Last Updated: December 21, 2020
• Results First Posted: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)