- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07645573
18F-FTHA IMAGING OF THE INTESTINAL AND CENTRAL LYMPHATIC SYSTEM (FTHA)
INVESTIGATION OF A POSITRON-EMITTING LONG-CHAIN FATTY ACID (18F-FTHA), FOR IMAGING OF THE INTESTINAL AND CENTRAL LYMPHATIC SYSTEM
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Initially up to 10 healthy adult volunteers will be recruited for the study. All subjects will be instructed to fast overnight before the scan visit. On the study day, subjects will be fasting, and then asked to consume an Ensure drink after [18F]FTHA administration and before imaging begins. Tracer administration vial oral capsules and PET/CT imaging: All subjects will receive approximately 1.0 -1.5 mCi (approximately 37-55 MBq) of [18F]FTHA administered orally followed by dynamic imaging for up to 4 hours, with breaks between scan sessions (Figure 4) on a whole-body PET/CT system.
An additional 15 patients with clinically suspected obstruction of the TD-venous junction with symptoms that may include chronic abdominal pain, edema, protein losing enteropathy and/or ascites, will be studied using the same administration and imaging procedures.
Participants with disease may undergo a standard of care clinical surgical bypass procedure and be asked to return post-surgery for a follow up PET/CT imaging session.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Erin K Schubert, BA
- Telefonnummer: 2155736569
- E-mail: erin.schubert@pennmedicine.upenn.edu
Undersøgelse Kontakt Backup
- Navn: Mary Hansbury, BS
- Telefonnummer: 215-746-8192
- E-mail: mary.hansbury@pennmedicine.upenn.edu
Studiesteder
-
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Rekruttering
- University of Pennsylvania Hospital
-
Kontakt:
- Erin Schubert
- Telefonnummer: 215-573-6569
- E-mail: erinschu@pennmedicine.upenn.edu
-
Ledende efterforsker:
- Paco Bravo, MD
-
Underforsker:
- Maxim Itkin, MD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
Inclusion Criteria (Healthy Volunteer Cohort)
- Male and female participants will be ≥ 18 years of age.
- "Healthy Volunteer" is defined for the purposes of this study as a volunteer who is in good general health in the opinion of an investigator (some well controlled chronic medical conditions may be allowed at the discretion of an investigator if they do not believe they will interfere with the collection of imaging data, specific excluded medical conditions are listed under exclusion criteria).
- Informed of the investigational nature of this study and able to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
Inclusion (Patient with suspected TD-venous junction obstruction cohort)
- Male and female participants will be ≥ 18 years of age
- Informed of the investigational nature of this study and able to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
- Patient with chronic abdominal pain, ascites protein losing enteropathy, as well edema, with clinically suspected obstruction of the TD-venous junction and who are candidates for TD-venous junction plasty and or TD-Venous bypass
Exclusion Criteria:
Exclusion Criteria that apply to Healthy Volunteers only
- Currently taking medication for cardiac disease, hypertension, hyperlipidemia, diabetes mellitus, heart failure, coronary artery disease, and/or history of cardiac surgery per medical record review and/or self-report
- Known history of liver or kidney disease per medical record review and/or self-report
Exclusion Criteria that applies to Healthy Volunteers and Patients:
- Women who are pregnant or breast feeding will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential on the day of each of the PET/CT scans.
- Subjects who report claustrophobia or Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
- Self-reported difficulty with swallowing pills or allergy to components of Ensure Plus
- Patients with a history of medical illness or disorder that in the opinion of an investigator and/or study physician could compromise patient safety or interfere with the collection of imaging data, or ability to complete the study and procedures, will be excluded.
Participant may not be involved in any other research studies involving ionizing radiation conducted within 1 year of their participation of this study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Healthy Volunteer
Healthy volunteers will undergo a single injection of [18F]-FTHA (a long-chain fatty acid positron emitting radiotracer) followed by up to 4 PET/CT scans.
|
Positron Emission Tomography/Computed Tomography (PET/CT) scans
|
|
Eksperimentel: TD-Venous Obstruction patients
Patients with known or suspected obstruction of the thoracic duct (TD)-venous junction will undergo a single injection of [18F]-FTHA (a long-chain fatty acid positron emitting radiotracer) followed by up to 4 PET/CT scans.
If the patient undergoes a clinical surgical procedure then they will be asked to undergo a second [18F]FTHA PET/Ct scan following the same procedure as the baseline scan.
|
Positron Emission Tomography/Computed Tomography (PET/CT) scans
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
FTHA transit time
Tidsramme: 4 weeks
|
To determine the normal [18F-]FTHA transit times through the intestinal lymphatic system, and TD among healthy human subjects imaged on a whole body PET/CT scanner.
|
4 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dosimetry
Tidsramme: 4 weeks
|
Calculation of radiation dosimetry from FTHA for whole body and individual organs will be completed.
|
4 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 857341
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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