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Neuroendocrine TumorPhase 1/2DOTA-TOCNCT02177773

GA-68 DOTA-TOC of Somatostatin Positive Malignancies

A Phase 1/2 study testing Computed Tomography (CT), Gallium Ga 68-Edotreotide and Magnetic Resonance Imaging (MRI) in people with Neuroendocrine Tumor and Paraganglioma, run by University of California, San Francisco at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase I/II trial studies how well gallium Ga 68-DOTA-TOC positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) works in imaging patients with somatostatin receptor positive tumors. Read more about this study

Who is it for?
Ages 2 years and older
What is being tested?
Computed Tomography (CT), Gallium Ga 68-Edotreotide and Magnetic Resonance Imaging (MRI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
23 Jun 2014to 7 Aug 2017
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Known or suspected somatostatin receptor positive tumor such as carcinoid; neuroendocrine tumor; neuroblastoma; pheochromocytoma. Supporting evidence may include MRI, CT, biochemical markers, and or pathology report.
  • Age > 1.
  • Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) equivalent).
  • Not pregnant. A negative serum pregnancy test is required for all female subjects with childbearing potential.
  • Ability to understand a written informed consent document, and the willingness to sign it.

Who cannot join

  • Hepatic enzymes 5 times greater than the upper limits of normal, serum creatinine > 3.0 mg/dL (270 Micromole per liter (uM/L).
  • Patients exceeding the 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.); although at Mission Bay Hospital pediatric patients may be sedated per clinical protocol.
  • 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.
  • Recognized concurrent active infection Previous systemic or radiation treatment for another cancer of any type within the last 2 months.
  • Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: Evaluation of Gallium-68 DOTA-TOC Imaging of Somatostatin Receptor Positive Malignancies

This phase I/II trial studies how well gallium Ga 68-DOTA-TOC positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) works in imaging patients with somatostatin receptor positive tumors. Gallium Ga 68-DOTA-TOC binds to somatostatin receptor positive tumors and can be seen using a PET scan. A PET scan uses a special camera to detect energy given off from gallium Ga 68-DOTA-TOC, to make detailed pictures of areas where material accumulates in the body. Diagnostic procedures, such as gallium Ga 68-DOTA-TOC PET/CT or PET/MRI, may help find and diagnose somatostatin receptor positive tumors and help plan the best treatment.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine if gallium Ga 68-DOTA-TOC (gallium-68 labeled DOTA-TOC) results in the delineation of more lesions than with conventional imaging.

SECONDARY OBJECTIVES:

  1. To determine if the incorporation of gallium (Ga)-68 DOTA-TOC PET/CT into the management decision making process results in a change in stage of the patient.

OUTLINE:

Patients receive gallium Ga 68-DOTA-TOC intravenously (IV) over 1-2 minutes. Within 55-70 minutes, patients then undergo a PET/CT scan over 30-40 minutes or a PET/MRI scan over 50 minutes.

After completion of study, patients are followed up for 2 weeks.

Being tested
Computed Tomography (CT), Gallium Ga 68-Edotreotide, Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET)
Medical subject headings
Neuroendocrine Tumors, Paraganglioma, Carcinoid Tumor, Neuroblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed Tomography (CT)Procedure or surgery

    Also called CAT, CAT Scan, Computed Tomography, Computerized Axial Tomography

    Undergo Gallium Ga 68-DOTA-TOC PET/CT

  • Gallium Ga 68-EdotreotideDrug

    Also called Ga-68 DOTA0-Tyr3-octreotide, GALLIUM EDOTREOTIDE GA-68, Gallium Ga 68-DOTATOC

    Given Intravenously (IV) before imaging

  • Magnetic Resonance Imaging (MRI)Procedure or surgery

    Also called Magnetic Resonance Imaging, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI

    Undergo gallium Ga 68-DOTA-TOC PET/MRI

  • Positron Emission Tomography (PET)Procedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography

    Undergo gallium Ga 68-DOTA-TOC PET in combination with CT or MRI

Study groups in NCT02177773
Study groupRoleWhat they receive
Ga-68 DOTA-TOC PET/CTExperimentalPatients receive Gallium Ga 68-DOTA-TOC IV over 1-2 minutes. Within 55-70 minutes, patients then undergo either a PET/CT scan lasting 30-40 minutes or a PET/MRI scan lasting 50 minutes.
Receives: Procedure: Computed Tomography (CT); Drug: Gallium Ga 68-Edotreotide; Procedure: Magnetic Resonance Imaging (MRI); Procedure: Positron Emission Tomography (PET)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Lesions as Determined by Gallium Ga 68-DOTA-TOC Positron Emission Tomography (PET) Imaging

    The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded The five largest lesions will be (1 = benign, 2 = likely benign, 3 = indeterminant, 4 = likely malignant, 5 = malignant). The number of positive body regions using conventional imaging and Ga-68 DOTA-TOC PET/CT will be compared using a paired t-test (or Wilcoxon signed-rank test if the data appear to be non-normally distributed). The Wilcoxon signed-rank test will also be used to compare reader confidence of paired lesions between conventional imaging and Ga-68 DOTA-TOC PET/CT

    Measured: 1 day

  2. Standardized Uptake Value Maximum (SUVmax)

    The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded.

    Measured: 1 day

  3. Inter-reader Variability

    Inter-reader variability for the number of positive regions will be compared using Kappa statistics. In all cases we will provide point estimates and 95% confidence intervals for effects along with p-values.

    Measured: 1 day

Secondary outcomes (1)

  1. Change in Clinical Stage as Determined by Conventional Imaging and Re-determined by Gallium Ga 68-DOTA-TOC PET Imaging

    Impact on care will be accessed for value added by the investigational Ga-68 DOTA-TOC PET/CT scan similar to assessment for impact on care as in the National Oncology PET registry. A percentage will then be calculated for both "Change in stage" with a 95% confidence interval determined.

    Measured: Up to 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2014 (estimated)
  2. Study start23 Jun 2014
  3. Primary completion7 Aug 2017
  4. Study completion7 Aug 2017

Why it stopped: FDA approved agent for this indication during enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02177773
Sponsor's protocol ID
14453-HDFCCC
Other IDs
NCI-2017-00451
Acronym
DOTA-TOC
Status last verified
Oct 2019
First submitted
25 Jun 2014
Last updated
12 Nov 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Computed Tomography (CT), Gallium Ga 68-Edotreotide and Magnetic Resonance Imaging (MRI) in people with Neuroendocrine Tumor and Paraganglioma, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Lesions as Determined by Gallium Ga 68-DOTA-TOC Positron Emission Tomography (PET) Imaging (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02177773.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.

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