68Ga-HA-DOTATATE PET/CT in Adults With Neuroendocrine Tumors
ConditionNeuroendocrine Tumors (NET)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorAlberta Health services
About this trial
To determine if 68Ga-HA-DOTATATE PET/CT imaging is effective at diagnosing somatostatin positive tumors compared to conventional imaging \[including CT, MRI, 111 In-pentetreotide Scans, 18F-FDG PET/CT, as available\]
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female. If female of child-bearing potential and outside of the window of 10 days since the last menstrual period, a negative pregnancy test will be required.
Age greater than or equal to 18 years.
Able and willing to follow instructions and comply with the protocol.
Provide written informed consent prior to participation in the study.
Disqualifiers
Nursing or pregnant females.
Age less than 18 years.
Surgery in the area of interest within the preceding 2 months.
Trial population
Clinically suspected (patients presenting with symptom(s) suggestive of carcinoid syndrome or biochemically suggestive of Neuroendocrine Tumor) or Biopsy proven Neuroendocrine Tumor. Patients greater than 18 years of age who are able to follow instructions and provide written consent to participate in study.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
68Ga-HA-DOTATATE PET/CT imaging
Diagnostic testEach patient will receive an IV injection 68Ga-HA-DOTATATE. Imaging will be conducted beginning 45-90 minutes after an injection of between 100-250 MBq 68Ga-HA-DOTATATE in patients. * After the 68Ga-HA-DOTATATE acquisition is complete, a CT scan will be performed for attenuation correction and localization in the same in line gantry without patient movement between the two scans. * The results of the 68Ga-HA-DOTATATE PET/CT will be compared to any prior imaging and pathologic results.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: 68Ga-HA-DOTATATE1 intervention
Trial outcomes
Primary outcomes
1
68Ga-HA-DOTATATE PET/CT imaging
To compare 68Ga-HA-DOTATATE PET/CT imaging at identifying somatostatin positive tumors to conventional imaging \[including CT, MRI, 111 In-pentetreotide Scans, 18F-FDG PET/CT, as available\]. 68Ga-HA-DOTATATE PET/CT scans will be evaluated for abnormal accumulation of 68Ga-HA-DOTATATE. Any abnormal uptake will be determined for up to 5 lesions and compared to results of standard of care imaging performed \[including CT, MRI, 111 In-pentetreotide (OctreoscanTM) Scan with SPECT/CT, 18F-FDG PET/CT, as available\] for presence/absence of each lesion. Comparison to any follow up 68Ga-HA-DOTATATE PET/CT Scans will also be performed (up to 5 follow up68Ga-HA-DOTATATE PET/CT Scans will be allowed).
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov