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

  • STATUS
    Recruiting
  • End date
    Aug 20, 2023
  • participants needed
    63
  • sponsor
    Clarity Pharmaceuticals Ltd
Updated on 7 October 2022

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.

Description

Up to 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.

Details
Condition Neuroendocrine Tumors
Treatment 64Cu-SARTATE
Clinical Study IdentifierNCT04438304
SponsorClarity Pharmaceuticals Ltd
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed informed consent
Age at enrolment ≥ 18 years
Life expectancy ≥ 12 weeks
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
Adequate recovery from acute toxic effects of any prior therapy
Adequate renal function (eGFR >30 ml/min)
Pre-study 68Ga-DOTATATE PET/CT scan performed within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SARTATE

Exclusion Criteria

Female participant who are pregnant or lactating
Participant has received any treatment (including experimental treatment) for their NET in the interval between 68Ga-DOTATATE PET/CT and 64Cu SARTATE PET/CT scan
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
Any serious medical condition or extenuating circumstance which the investigator believes may interfere with the procedures or evaluations of the study
Active oncologic therapy within 8 weeks prior to the 68GaDOTATATE PET/CT scan (long-acting somatostatin analogues are permitted and not considered active oncological treatment)
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)
Participants with diffuse or infiltrative hepatic involvement based on the pre-study 68Ga-DOTATATE PET/CT scan
Participants with extensive marrow/skeletal involvement (>20 lesions) based on the pre-study 68Ga-DOTATATE PET/CT scan
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