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

Primary Purpose

Neuroendocrine Tumors, Carcinoid Tumors, Neuroblastoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

68Ga-DOTATOC PET/CT

About this trial

This is an interventional diagnostic trial for Neuroendocrine Tumors

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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%).

Sites / Locations

University of Iowa Hospitals and Clinics

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

68Ga-DOTATOC PET/CT

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02441062

First Posted

May 4, 2015

Last Updated

December 17, 2020

Sponsor

Sue O'Dorisio

Collaborators

University of Iowa

1. Study Identification

Unique Protocol Identification Number

NCT02441062

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

September 2015 (Actual)

Primary Completion Date

January 20, 2020 (Actual)

Study Completion Date

January 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sue O'Dorisio

Collaborators

University of Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This is a prospective, Phase II, single center, open-label study in a total of 200 participants with histologically proven neuroendocrine tumor or other somatostatin receptor positive tumors. Eligible participants will undergo baseline assessments at enrollment. They will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Participants may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuroendocrine Tumors, Carcinoid Tumors, Neuroblastoma, Medulloblastoma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

68Ga-DOTATOC PET/CT

Arm Type

Other

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

68Ga-DOTATOC PET/CT

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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%).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary S O'Dorisio, MD, PhD

Organizational Affiliation

University of Iowa

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Iowa Hospitals and Clinics

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23587853

Citation

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.

Results Reference

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

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