Evaluation of V-Cu64 versus V-Ga68 PET-CT imaging in adults with diagnosed or suspected neuroendocrine tumors

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What is this study about?

The study focuses on patients who have or are suspected of having neuroendocrine tumors. These are growths that arise from hormone‑producing cells. To see these tumors, a special type of scan called PET-CT is used. The scan works by injecting a tiny amount of a substance that gives off a signal that the scanner can detect. In this trial the new substance contains a radioactive form of copper, identified as V-Cu64, which is attached to a molecule named DOTATOC. The standard substance used in current practice contains a radioactive form of gallium, called 68Ga, also linked to the same molecule. The main goal is to find out whether the new copper‑based agent provides images that are as clear as those from the gallium‑based agent.

Participants will receive an injection of the copper‑based agent and then undergo a scan. After a short break, they will receive the standard gallium‑based agent and have a second scan. Doctors will compare the number of tumors seen and a measurement called SUV_MAX, which reflects how bright each tumor appears on the images. The study also includes monitoring for any side effects. The overall time each participant spends in the study is limited to a few visits over several weeks.

1 initial imaging with 68ga‑labeled dotatoc

after enrolment, you attend the first appointment at the imaging centre.

a healthcare professional inserts a small needle into a vein (intravenous) and injects 200 mbq of 68ga‑labeled dotatoc. mbq stands for megabecquerel, a unit that measures radioactivity.

shortly after the injection, you lie on a table while a pet‑ct scanner creates detailed pictures of any neuroendocrine tumor tissue.

the whole procedure usually takes a few hours, after which you can leave the centre.

2 second imaging with v‑cu64‑labeled dotatoc

on a later date within the study period, you return for the second imaging session.

again, a needle is placed in a vein and 200 mbq of v‑cu64‑labeled dotatoc is injected. v‑cu64 is a radioactive form of copper used for imaging.

the pet‑ct scanner is used in the same way to obtain images of the same areas examined previously.

the duration of this visit is similar to the first, lasting a few hours.

3 safety monitoring and follow‑up

after each imaging session, you are asked to report any new symptoms or discomfort to the study staff.

the study records any adverse events, which are any unwanted medical occurrences, to evaluate safety of the radiopharmaceuticals.

no additional medication is taken beyond the described injections.

Who Can Join the Study?

You must have a confirmed or suspected neuroendocrine tumor (NET) based on a tissue sample examined by a pathologist (called a histology/biopsy report).
You must have a confirmed or suspected NET shown by imaging tests such as an MRI (magnetic resonance imaging), a CT scan with contrast (x‑ray pictures with a dye to highlight structures), or special scans called PET‑CT (using either FDG or NaF tracers). These scans must have been done within the last 8 weeks.
You must have a confirmed or suspected NET based on blood or urine tests that show higher than normal levels of substances such as chromogranin A, pancreatic polypeptide, neuron‑specific enolase, vasoactive intestinal peptide, serotonin (measured as 5‑HIAA in urine), gastrin, somatostatin, catecholamines, metanephrine, calcitonin, fasting insulin, C‑peptide (or proinsulin), and glucagon.
If you have a family history that puts you at higher risk for NET, such as known genetic conditions called MEN1 or VHL, you may be eligible, whether you have symptoms or not.
Your recent blood work must be within safe limits: white blood cells higher than 2 × 10⁹ per liter, hemoglobin (the protein that carries oxygen) above 8.0 g/dL, platelets (cells that help clot blood) above 50 × 10⁹ per liter, and kidney function measured by serum creatinine below 170 µmol/L.
You must have a negative urine or blood pregnancy test, or be postmenopausal for at least 2 years, or have had a hysterectomy, and you must agree to use barrier or hormonal birth control during the study and for at least 3 months after it ends.

Who Cannot Join the Study?

Pregnancy or lactation: You cannot take part if you are currently pregnant or are nursing a baby.
Inability to give written consent: You must be able to sign a form agreeing to join the study; if you cannot do this, you are excluded.
Use of somatostatin analogue within the past 28 days: This means any medication that works like the natural hormone somatostatin (used to treat certain tumors) must not have been taken in the four weeks before the scan.
Serious health problems: Includes uncontrolled congestive heart failure (the heart cannot pump blood well), liver dysfunction (the liver is not working properly), renal dysfunction (the kidneys are not working properly), or uncontrolled high blood pressure (hypertension). If you have any of these conditions, you cannot participate.
History of hypersensitivity: If you have had an allergic reaction to drugs that are chemically similar to the study medication or to any of its inactive ingredients (called excipients), you are not eligible.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
NZOZ Medyczne Centra Diagnostyczne VOXEL Zakład Medycyny Nuklearnej	Katowice	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not yet recruiting	01.03.2026

Trial locations

Investigated drugs:

V-Cu64 is a radioactive copper‑based tracer that is attached to a molecule called DOTATOC. In this study it is the new test agent that is injected into the patient before a PET‑CT scan. The purpose is to see if it can show neuroendocrine tumors as clearly as the standard method.

V-Ga68 is a radioactive gallium‑based tracer also linked to DOTATOC. It is used as the comparator, or “gold standard,” in the trial. Patients receive this agent before a PET‑CT scan to provide the reference images that the new test will be compared against.

Gallium‑68 DOTATOC is a well‑known radiopharmaceutical that binds to receptors on neuroendocrine tumor cells. It is injected before a PET‑CT scan to highlight the tumors, helping doctors locate and assess them. In the trial it serves as background information to show how the standard imaging works.

SomaKit TOC is a preparation kit that contains the peptide DOTATOC. The kit is used to make the radiopharmaceuticals (like the gallium‑68 or copper‑64 versions) by adding the radioactive metal. It provides the essential component that allows the tracer to target tumor cells during imaging.

Neuroendocrine tumor – A growth that starts in cells that release hormones into the blood. These tumors can appear in many parts of the body, most often in the pancreas or gastrointestinal tract. They may grow slowly and stay small for a long time, or they can become larger and form new lumps. Over time, the tumor cells can spread to nearby lymph nodes or distant organs. The size and number of tumors may increase as the condition progresses.

Trial ID:

2025-524050-34-01

Protocol code:

CuDota25

Trial Phase:

Therapeutic confirmatory (Phase III)

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Evaluation of V-Cu64 versus V-Ga68 PET-CT imaging in adults with diagnosed or suspected neuroendocrine tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?