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A Diagnostic Imaging Study of 64Cu-SARTATE Using PET on Patients With Known or Suspected Neuroendocrine Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04438304
Recruitment Status : Not yet recruiting
First Posted : June 18, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Clarity Pharmaceuticals Ltd

Brief Summary:
The purpose of this study is to assess the performance of imaging agent 64Cu-SARTATE in participants with known or suspected Gastroenteropancreatic (GEP) Neuroendocrine Tumors (NETs) as a potential new way to help diagnose NETs.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: 64Cu-SARTATE Phase 2

Detailed Description:
A total of 63 participants will be recruited in this study and who are confirmed or suspected to have NETs based on biochemical evidence or that of conventional anatomical or molecular imaging.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Positron Emission Tomography Imaging of Participants With Known or Suspected Neuroendocrine Tumours Using 64Cu SARTATE: A Multi-Centre, Single Arm, Non-Randomised, Blinded-Review, Phase II Study
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
64Cu-SARTATE will be administered at a fixed administration dose of 200 MBq (5.4 mCi) given as a single bolus intravenous injection.
Drug: 64Cu-SARTATE
64Cu-SARTATE will be administered at a fixed administration dose, single bolus intravenous injection, peptide mass not exceeding 20µg.
Other Name: 64Cu-MeCOSar-Octreotate




Primary Outcome Measures :
  1. Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings [ Time Frame: At 4 hours post administration of 64Cu-SARTATE ]
    Sensitivity and specificity on the 4-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.

  2. Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings [ Time Frame: At 20 hours post administration of 64Cu-SARTATE ]
    1. Sensitivity and specificity on the 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.
    2. Sensitivity and specificity on composite of 4-hour and 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.

  3. To assess the proportion of concordance between 4-hour 64Cu-SARTATE to that of 68Ga-DOTATATE [ Time Frame: At 4 hours post administration of 64Cu-SARTATE ]
    Concordance measured on a per-lesion basis


Secondary Outcome Measures :
  1. To compare the diagnostic performance of 64Cu-SARTATE to 68Ga-DOTATATE on a per-participant basis in participants with suspected disease only. [ Time Frame: At 4 hours and 20 hours post administration of 64Cu-SARTATE ]
    1. Sensitivity and specificity of the 4-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.
    2. Sensitivity and specificity of the 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.
    3. Sensitivity and specificity on composite of 4-hour and 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.

  2. Incidence of adverse events related to 64Cu-SARTATE [ Time Frame: 1 week post administration of 64Cu-SARTATE ]
    Adverse events will be graded using the national cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent;
  2. Age at diagnosis ≥ 18 years;
  3. Life expectancy ≥ 12 weeks;
  4. Known diagnosis of GEP NET or suspicion of GEP NET based on axial imaging (e.g. on CT and/or MRI and/or FDG) and/or biochemical evidence of NET;
  5. Adequate recovery from acute toxic effects of any prior therapy;
  6. Adequate renal function (eGFR >30 ml/min);
  7. Pre-study 68Ga-DOTATATE PET/CT scan performed within 4 weeks, but not closer than 6 hours prior to the administration of 64Cu-SARTATE;
  8. A diagnostic CT scan and/or MRI scan skull to mid-thigh within 4 weeks prior to the administration of 64Cu-SARTATE is available.

Exclusion Criteria:

  1. Disease of any major organ system that would compromise their ability to tolerate a PET/CT scan, as deemed by the investigator;
  2. Female participant who are pregnant or lactating;
  3. Male or female participant of childbearing potential not willing to practice an effective method of birth control while participating on the study to avoid possible damage to the foetus. Abstinence is considered acceptable;
  4. Participant has received any treatment for their NET in the interval between 68Ga-DOTATATE PET/CT and 64Cu SARTATE PET/CT scan;
  5. Any serious medical condition or extenuating circumstance which the investigator believes may interfere with the procedures or evaluations of the study;
  6. History of other active malignancy within the last 2 years the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, in-situ carcinoma of the uterine cervix, or prostate cancer that is controlled by hormone therapy (patients may continue hormone therapy while on study).
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Responsible Party: Clarity Pharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT04438304    
Other Study ID Numbers: CLS07
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue