--- title: Test imaging tracer for Parkinson nct_id: NCT07617688 phase: EARLY_PHASE1 status: RECRUITING sponsor: MODAG GmbH study_type: INTERVENTIONAL canonical_url: "https://parkinsonspathways.com/trial/NCT07617688" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07617688" last_fetched: "2026-06-04T14:00:06.170Z" source: "Parkinson's Pathways (curated)" --- # Test imaging tracer for Parkinson **Goal (in five words):** Test imaging tracer for Parkinson **Official Title:** Evaluation of the Pharmacokinetics, Biodistribution and Radiation Dosimetry of [18F]MODAG-009 Positron Emission Tomography (PET) Radiotracers in Adult Healthy Volunteers **Trial ID:** [NCT07617688](https://clinicaltrials.gov/study/NCT07617688) ## Key Facts - **Phase:** EARLY_PHASE1 - **Status:** RECRUITING - **Study Type:** INTERVENTIONAL - **Sponsor:** MODAG GmbH - **Target Enrollment:** 6 participants - **Start Date:** 2026-05-27 - **Completion Date:** 2027-05 - **Conditions:** Healthy Adult - **Interventions:** [¹⁸F]MODAG-009 PET Imaging - **Intervention Types:** DRUG ## Summary For Families The goal is to learn how a new PET imaging tracer behaves in the body and how much radiation it gives, as a first safety step toward using it for brain imaging related to Parkinson’s research. Participants receive a tiny dose of [18F]MODAG-009, a small molecule labeled with fluorine-18 that emits positrons so the PET camera can map where the tracer goes, how quickly it clears, and how much each organ absorbs; it is an imaging agent, not a treatment, and it does not affect levodopa. Scans and blood tests let investigators calculate pharmacokinetics, organ uptake, and radiation dosimetry to guide safe use in future studies. Healthy adults 18 to 60 who can consent are eligible, but people who are pregnant or breastfeeding, on recent medications, with significant medical issues, recent heavy radiation exposure, recent tobacco use, or recent large blood loss are excluded. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 60 Years - **Sex:** ALL ### Full Criteria ``` Inclusion Criteria: * Male or Female, * aged 18 to 60 years old * in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. * Ability to comply with the study procedures. * Able to understand and sign written informed consent from the participant. * Male and Females must meet additional criteria specified below, as applicable * a. Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to until at least 24 hours after injection of \[18F\]MODAG-009. (i. Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to PET scan) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy). ii. Highly effective method of birth control is defined as practicing at least one of the following: A birth control method that results in a less than 1% per year failure rate when used consistently and correctly, such as oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.) * b. Females of childbearing potential must not be pregnant, breastfeeding or lactating, or planning pregnancy during the duration of the study. * c. Males with female partners of childbearing potential must use adequate contraceptive methods and refrain from sperm donation for 90 days after injection of \[18F\]MODAG-009 Exclusion Criteria: * Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing. If needed (i.e. an incidental and limited need), acetaminophen is acceptable, but must be documented as a concomitant medication / significant non-drug therapy. Participation in any clinical interventional studies within four (4) weeks prior to initial dosing or 5 half-lives of the investigational agent if known and longer than four (4) weeks. * Participants with a history of exposure to any radiation \>50 mSv/year (e.g., occupational or radiation therapy) over the past year. Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulation. * Have a history or presence of any significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorders which, in the opinion of the investigator, are capable of altering the absorption, metabolism, or elimination of drugs or posing a health risk to participate in the study. * Have clinically significant findings on laboratory evaluations. * Have clinically significant findings on ECG evaluation. * History of immunodeficiency diseases, including a positive HIV test result. * A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody test result. * History of drug or alcohol abuse within the 12 months prior to screening, or evidence of such abuse as indicated by the laboratory assays conducted during the screening. * History of tobacco product use within 3 months prior to screening, to be verified by urine cotinine screening. * Positive pregnancy test result, if female. * Women who are lactating and breastfeeding. ``` ## Locations (1) - Institute for Neurodegenerative Disorders and XingImaging, LLC, New Haven, Connecticut, United States _(41.3081, -72.9282)_ - Stephanie Roman — (CONTACT) — 475-318-8250 — sroman@xingimaging.com - Neha Prakash, MBBS — (PRINCIPAL_INVESTIGATOR) ## Central Contacts - Johannes Levin, MD — (CONTACT) — 475-318-8250 — levin@modag.net - Stephanie Roman — (CONTACT) — 475-318-8250 — sroman@xingimaging.com --- *Canonical: https://parkinsonspathways.com/trial/NCT07617688* *HTML version: https://parkinsonspathways.com/trial/NCT07617688* *Source data: https://clinicaltrials.gov/study/NCT07617688*