Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 68Ga-DOTATOC PET/CT 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
Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With a Change in Treatment Management Based on Findings of the Gallium Ga 68-edotreotide PET/CT Scan [36 months]
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.
Eligibility Criteria
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%).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
Sponsors and Collaborators
- Sue O'Dorisio
- University of Iowa
Investigators
- Principal Investigator: Mary S O'Dorisio, MD, PhD, University of Iowa
Study Documents (Full-Text)
More Information
Publications
- 201503708
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 68Ga-DOTATOC PET/CT |
|---|---|
| Arm/Group 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. 68Ga-DOTATOC PET/CT: Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors |
| Period Title: Overall Study | |
| STARTED | 122 |
| COMPLETED | 122 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | 68Ga-DOTATOC PET/CT |
|---|---|
| Arm/Group 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. 68Ga-DOTATOC PET/CT: Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors |
| Overall Participants | 122 |
| Age (Count of Participants) | |
| <=18 years |
9
7.4%
|
| Between 18 and 65 years |
98
80.3%
|
| >=65 years |
15
12.3%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
61
50%
|
| Male |
61
50%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
1
0.8%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
4
3.3%
|
| White |
104
85.2%
|
| More than one race |
1
0.8%
|
| Unknown or Not Reported |
12
9.8%
|
| Region of Enrollment (participants) [Number] | |
| United States |
122
100%
|
Outcome Measures
| Title | Number of Participants With a Change in Treatment Management Based on Findings of the Gallium Ga 68-edotreotide PET/CT Scan |
|---|---|
| Description | 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. |
| Time Frame | 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study stopped early, 114 of the 122 patients enrolled were analyzed for outcome measure |
| Arm/Group Title | 68Ga-DOTATOC PET/CT |
|---|---|
| Arm/Group 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. 68Ga-DOTATOC PET/CT: Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors |
| Measure Participants | 114 |
| Major change |
54
44.3%
|
| Minor change |
6
4.9%
|
| No change |
54
44.3%
|
Adverse Events
| Time Frame | Adverse events collected at the time of scan, 1 day post scan, and 6-18 months post scan. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | 68Ga-DOTATOC PET/CT | |
| Arm/Group 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. 68Ga-DOTATOC PET/CT: Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors | |
All Cause Mortality |
||
| 68Ga-DOTATOC PET/CT | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/122 (1.6%) | |
Serious Adverse Events |
||
| 68Ga-DOTATOC PET/CT | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/122 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| 68Ga-DOTATOC PET/CT | ||
| Affected / at Risk (%) | # Events | |
| Total | 42/122 (34.4%) | |
| Blood and lymphatic system disorders | ||
| Blood and lymphatic system disorders | 1/122 (0.8%) | 1 |
| Gastrointestinal disorders | ||
| Abdominal pain | 1/122 (0.8%) | 2 |
| Bloating | 1/122 (0.8%) | 1 |
| Diarrhea | 7/122 (5.7%) | 8 |
| Flatulence | 1/122 (0.8%) | 1 |
| Gastroesophageal reflux disease | 1/122 (0.8%) | 1 |
| Nausea | 8/122 (6.6%) | 11 |
| Vomiting | 1/122 (0.8%) | 2 |
| General disorders | ||
| Fever | 2/122 (1.6%) | 2 |
| Pain | 2/122 (1.6%) | 2 |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 3/122 (2.5%) | 3 |
| Musculoskeletal and connective tissue disorder | 2/122 (1.6%) | 2 |
| Pain in extremity | 1/122 (0.8%) | 1 |
| Nervous system disorders | ||
| Dizziness | 3/122 (2.5%) | 3 |
| Dysgeusia | 1/122 (0.8%) | 1 |
| Headache | 3/122 (2.5%) | 3 |
| Paresthesia | 1/122 (0.8%) | 2 |
| Vascular disorders | ||
| Flushing | 3/122 (2.5%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | M.Sue O'Dorisio |
|---|---|
| Organization | University of Iowa, Holden Comprehensive Cancer Center |
| Phone | (319) 335-7234 |
| sue-odorisio@uiowa.edu |
- 201503708