[18F]ZDG2 First-in-Human PET Imaging in PAH
NCT07934264, Early phase 1, Not yet recruiting, The Methodist Hospital Research Institute
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | [18F]ZDG2 First-in-Human PET Imaging in PAH | ClinicalTrials.gov |
| NCT number | NCT07934264 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Early phase 1 | ClinicalTrials.gov |
| Enrollment | 20 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | The Methodist Hospital Research Institute | ClinicalTrials.gov |
| Conditions | Pulmonary Artery Hypertension | ClinicalTrials.gov |
| Interventions | [18F]ZDG2- Single Dose | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence and severity of adverse events | From enrolment to the final follow up visit, 3-7 days after the last dose. | Incidence recorded and severity graded per CTCAE v6.0 | ClinicalTrials.gov |
| Primary | Changes in blood pressure from baseline | From enrolment to the final follow up visit, 3-7 days after the last dose. | Systolic and diastolic (mmHg) | ClinicalTrials.gov |
| Primary | Changes in heart rate from baseline | From enrolment to the final follow up visit, 3-7 days after the last dose. | (bpm) | ClinicalTrials.gov |
| Primary | Changes in oxygen saturation from baseline | From enrolment to the final follow up visit, 3-7 days after the last dose. | As measured via pulse oximetry (%) | ClinicalTrials.gov |
| Primary | Changes in temperature from baseline | From enrolment to the final follow up visit, 3-7 days after the last dose. | (°C or °F) | ClinicalTrials.gov |
| Primary | Standardized uptake values in major organs | From tracer administration to the final scan at 180 minutes post administration | (SUVmax, SUVmean) | ClinicalTrials.gov |
| Primary | Number of participants with abnormal results in hematology assessments | From enrolment to the final follow up visit, 3-7 days after the last dose. | The following will be assessed as part of the hematology panel: WBC, Platelet count, RBC, Neutrophils, HGB, Lymphocytes, HCT, Monocytes, MCV, Eosinophils, MCH, Basophils, MCHC Changes from baseline and results outside of the normal range will be evaluated by the PI and safety committee for clinical significance. | ClinicalTrials.gov |
| Primary | Number of participants with abnormal results in chemistry laboratory assessments | From enrolment to the final follow up visit, 3-7 days after the last dose. | The following will be assessed as part of the chemistry panel: Sodium, Calcium, Potassium, Protein, Chloride, Albumin, CO2, Alkaline phosphatase, BUN, AST, Creatinine, ALT, Glucose, Total bilirubin, eGFR Changes from baseline and results outside of the normal range will be evaluated by the PI and safety committee for clinical significance. | ClinicalTrials.gov |
| Primary | Number of participants with abnormal results in coagulation laboratory assessments | From enrolment to the final follow up visit, 3-7 days after the last dose. | The following will be assessed as part of the coagulation panel: INR, Prothrombin time (PT) Changes from baseline and results outside of the normal range will be evaluated by the PI and safety committee for clinical significance. | ClinicalTrials.gov |
| Primary | Number of participants with abnormal results in urinalysis laboratory assessments | From enrolment to the final follow up visit, 3-7 days after the last dose. | The following will be assessed as part of the urinalysis panel: Color, Bilirubin, Appearance, Blood, Specific gravity, Nitrite, pH, Urobilinogen, Protein, WBC, Glucose, RBC, Ketones Changes from baseline and results outside of the normal range will be evaluated by the PI and safety committee for clinical significance. | ClinicalTrials.gov |
| Primary | Number of participants with abnormal results in NTproBNP laboratory assessments | From enrolment to the final follow up visit, 3-7 days after the last dose. | Changes from baseline and results outside of the normal range will be evaluated by the PI and safety committee for clinical significance. (pg/mL) | ClinicalTrials.gov |
| Primary | Number of participants with abnormal results in HgbA1c laboratory assessments | From enrolment to the final follow up visit, 3-7 days after the last dose. | Changes from baseline and results outside of the normal range will be evaluated by the PI and safety committee for clinical significance. (%) | ClinicalTrials.gov |
| Primary | Time-activity curves for major organs including lungs and heart | From tracer administration to the final scan at 180 minutes post administration | Organ radioactivity concentration measured over time following tracer administration. | ClinicalTrials.gov |
| Primary | Identification of excretory pathways | From tracer administration to the final scan at 180 minutes post administration | Determined from serial PET imaging and biologic sample analysis following tracer administration. | ClinicalTrials.gov |
| Primary | Radiation Dosimetry | From tracer administration to the final scan at 180 minutes post administration. | We will calculate organ-specific absorbed radiation doses and the total effective dose. | ClinicalTrials.gov |
| Primary | Plasma concentration-time profile | From tracer administration to the final scan at 180 minutes post administration | Plasma tracer concentration measured at multiple timepoints following administration. | ClinicalTrials.gov |
| Primary | Parent fraction analysis | From tracer administration to the final scan at 180 minutes post administration | metabolite profiling | ClinicalTrials.gov |
| Primary | Plasma free fraction determination | From tracer administration to the final scan at 180 minutes post administration | Fraction of tracer unbound to plasma proteins, reported as a percentage. | ClinicalTrials.gov |
| Secondary | VEGFR Quantification | From 90 minutes post tracer administration to 180 minutes post administration. | We will quantify pulmonary artery and right ventricular VEGFR expression in PAH patients compared to healthy volunteers. | ClinicalTrials.gov |
| Secondary | Mean pulmonary artery pressure | From tracer administration to the final scan at 180 minutes post administration | As measured via standard of care heart catheterization | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)