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

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clarity Pharmaceuticals Ltd

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).