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Evaluation of D-Glucose-13C6 Test for Detecting SDHx Mutations in Patients with Pheochromocytoma or Paraganglioma

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial involves individuals who have paraganglioma or pheochromocytoma that need to be removed by surgery. These rare tumors can be linked to a hereditary change called an SDHx mutation. The study uses an intravenous infusion of a specially labeled sugar, D-Glucose-13C6, given as a solution for infusion.

The purpose of the study is to determine how well this test can serve as a biomarker for detecting the SDHx mutation by measuring a unique pattern of sugar metabolism in the blood, and to compare the results with standard genetic testing. A biomarker is a measurable sign that can indicate the presence of a disease or a genetic change.

Participants will receive the sugar infusion, have blood drawn at several time points, and then undergo the planned tumor removal surgery. The blood samples will be examined for the specific metabolic pattern, and the findings will be compared with tumor size seen on imaging and with the tissue analysis after surgery. The study follows each person from the infusion through the surgical procedure and a short follow‑up period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment

    Upon joining the study you attend a baseline visit where medical history and current medications are recorded.

    A capillary blood glucose measurement is taken and a small blood sample is collected for later laboratory analysis.

  2. Step 2

    D-glucose-13c6 infusion

    You receive an intravenous infusion of d-glucose-13c6 at a dose of 24 g dissolved in a solution for infusion.

    The infusion is given through a vein as a single administration; no repeated dosing is required.

  3. Step 3

    Post‑infusion blood sampling

    Several blood samples are drawn from a vein at predefined times after the infusion to measure the presence of a specific 13c6‑glucose metabolism profile in plasma.

    Capillary blood glucose is also measured at each sampling time to monitor glucose levels.

  4. Step 4

    Surgical tumor removal

    If surgery is already planned for your condition, the tumor is removed according to standard clinical practice.

    The resected tumor is sent to the laboratory for analysis of its metabolic profile and for comparison with imaging findings.

  5. Step 5

    Laboratory analysis

    Plasma samples are examined to determine whether the 13c‑biomarker is present.

    The tumor tissue is analyzed to assess its metabolic characteristics and to relate these findings to the pre‑operative imaging and tumor weight.

  6. Step 6

    Final assessment

    After all measurements are completed, the study data are compared with the results of genetic testing for an sd hx mutation, which serves as the reference standard.

    You receive information about the study results according to the usual clinical follow‑up procedures.

Who can join the trial?

4 criteria

  • Be a man or woman who is older than 18 years.
  • Have a diagnosis of paraganglioma or pheochromocytoma (rare tumors that can affect hormone levels) confirmed by either imaging tests (such as scans) or by measuring substances called metanephrines in the blood or urine, and the doctor must recommend surgery to remove the tumor.
  • Agree to take part by signing the consent form, which explains the study and your rights.
  • Be enrolled in a social security system, meaning you have the usual government health coverage.

Who cannot join the trial?

7 criteria

  • Uncontrolled diabetes with an HbA1c level higher than 8% – HbA1c is a blood test that shows average blood sugar over the past three months; a high level means diabetes is not well‑controlled.
  • Insulin‑treated diabetes – this means you need to take insulin injections to control your blood sugar.
  • Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m² – eGFR is a lab measurement that tells how well the kidneys are working; a very low value shows poor kidney function.
  • Contraindication to glucose administration – a medical reason that makes giving glucose unsafe for you.
  • Pregnancy or breastfeeding – being pregnant or nursing a baby makes participation not allowed.
  • Being under guardianship, conservatorship, or judicial protection – legal situations where you cannot give full consent yourself.
  • Currently taking part in another ongoing clinical trial or a study whose required waiting period has not finished, except for the specific PREPA PHEO and COMETE CARE studies that do not interfere with this research.
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Investigated drugs

D-Glucose-13C6 is a specially labeled form of glucose that is given through an IV line during the study. It allows researchers to track how the body processes sugar in real time. By watching how this labeled glucose moves through the cells, doctors can see patterns that may indicate whether a person has a genetic mutation in the SDHx genes, which are linked to certain tumor types. This test helps determine if the new biomarker can accurately identify patients with the mutation compared to standard genetic testing.

What is already known about the treatment

D-Glucose-13C6 - D-Glucose-13C6 is administered intravenously as a sterile solution for infusion, typically at a dose of 24 g. It is an investigational, stable‑isotope labeled form of glucose used in research and not approved as a therapeutic drug. The test is used to help identify paraganglioma or pheochromocytoma tumors in patients with SDHx gene mutations by tracking how the labeled sugar is taken up and processed by tumor cells. It works by entering cells like normal glucose and being metabolized, allowing scientists to measure metabolic activity, and it belongs to the class of isotopic tracer agents.

Investigated diseases

Pheochromocytoma and paraganglioma - These are rare tumors that arise from cells that normally produce adrenaline and related hormones. They can develop in the adrenal gland (pheochromocytoma) or in nerve tissue outside the gland (paraganglioma). The tumors often grow slowly at first, but may increase in size over time. As they enlarge, they can release excess hormones into the bloodstream, leading to episodes of high blood pressure, rapid heart rate, and sweating. Some tumors can spread to nearby lymph nodes or distant organs, where they continue to grow. The disease course varies, with some lesions remaining localized while others become more widespread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506001-19-00Protocol codeAPHP190612Estimated enrolment10 patientsSponsorAssistance Publique Hopitaux De Paris

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