CompletedPhase 1/2

68Ga-OPS202 Study for Diagnostic Imaging of GEP NET

Switzerland12 participantsStarted 2014-06

Plain-language summary

The purpose of this study is to assess the safety and tolerability of 68Ga-OPS202 used for the diagnosis of gastroenteropancreatic neuroendocrine tumors (GEP NETs).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * A diagnostic CT or MRI of the tumor region within the previous 6 months prior to dosing day is available. * A somatostatin receptor scan with results in the previous 6 months prior to dosing day. * At least 1 lesion detected by the previous somatostatin receptor scan. * Not exceeding 30 lesions / organ detected by the previous somatostatin receptor scan. * Blood test results as follows (WBC: ≥ 3\*109/L, Hemoglobin: ≥ 8.0 g/dL, Platelets: ≥ 50x109/L, ALT, AST, AP: ≤ 5 times ULN, Bilirubin: ≤ 3 times ULN) * ECG: any abnormalities have to be clarified by a cardiologist. * Serum creatinine: within normal limits or \< 120 μmol/L for patients aged 60 years or older. * Calculated GFR ≥ 45 mL/min. * Negative pregnancy test in women capable of child-bearing. Exclusion Criteria: * Known hypersensitivity to 68Ga, to NODAGA, to JR11 or to any of the excipients of 68Ga-OPS202. * History of, or current active allergic or autoimmune disease, including asthma or any condition requiring long-term use of corticosteroids. * Presence of active infection at screening or history of serious infection within the previous 6 weeks. * Known human immunodeficiency virus (HIV) or positive serology for HIV, hepatitis B and C. * Any condition that precludes raised arms position for prolonged imaging purposes. * Neuroendocrine tumor specific treatment between last somatostatin receptor imaging and start of this study. Exception is the therapeutic use of any somatostatin analog (see …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs)

Timeframe: From start of IP administration to end of the study visit (approximately 28 to 36 days)

Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication

Timeframe: From start of IP administration to end of the study visit (approximately 28 to 36 days)

Trial details

NCT IDNCT02162446

SponsorIpsen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-06

Results submitted2019-07-05

View on ClinicalTrials.gov More Gastroenteropancreatic Neuroendocrine Tumors trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs)

Timeframe: From start of IP administration to end of the study visit (approximately 28 to 36 days)

Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication

Timeframe: From start of IP administration to end of the study visit (approximately 28 to 36 days)