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Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

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

Short name GA-68

NCTNCT01619865 (opens ClinicalTrials.gov in a new tab)Other id201110718Other id114398
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Octreotide, does not test it. It appears in the title.

Overview

Status
Completed
Phase
Phase 1/2
Enrollment
223 participants (actual)
Sponsor
Sue O'Dorisio · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
21 Feb 2012
Primary completion
27 Aug 2017
Completion
27 Aug 2017
First posted
14 Jun 2012 (estimated)
Last update posted
27 Jul 2021
Conditions
Neuroendocrine Tumors · Carcinoid Tumors · Neuroblastoma · Medulloblastoma

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015201620172018
  1. Ph 1/2

    GA-68

    NCT01619865

    21 Feb 2012 to 27 Aug 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • 68Ga-DOTATOC PET/CTDrug

Arms1

  • Experimental

    68Ga-DOTATOC PET/CT

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

Primary outcomes2

Outcomes the sponsor listed as primary.

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

    Time frame · During PET scan and 24 hours post scan

    Registry description

    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.

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

    Time frame · Up to 6 months

    Registry description

    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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· During PET scan and 24 hours post scan

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

GroupValue (Adverse events reported)
68Ga-DOTATOC PET/CT18
Primary outcomeCount of participants· Up to 6 months

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

GroupValue (Participants)
68Ga-DOTATOC PET/CT118

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
68Ga-DOTATOC PET/CT68Ga-DOTATOC Positron Emission Tomography (PET) for Diagnosis, Staging, and Measurement of Response to Treatment in Somatostatin Receptor Positive Tumors 68Ga-DOTATOC PET/C: 1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV.2 / 2231 / 223176 / 223

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultAbongwa 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
  • ResultMenda 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

Eligibility

Who could join, as posted.

Sex
All
Age
from 2 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. Exclusion Criteria: * 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?

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