- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Frühphase 1
Kontakte und Standorte
Studienkontakt
- Name: Erin K Schubert, BA
- Telefonnummer: 2155736569
- E-Mail: erin.schubert@pennmedicine.upenn.edu
Studieren Sie die Kontaktsicherung
- Name: Mary Hansbury, BS
- Telefonnummer: 215-746-8192
- E-Mail: mary.hansbury@pennmedicine.upenn.edu
Studienorte
-
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- Rekrutierung
- University of Pennsylvania Hospital
-
Kontakt:
- Erin Schubert
- Telefonnummer: 215-573-6569
- E-Mail: erinschu@pennmedicine.upenn.edu
-
Hauptermittler:
- Paco Bravo, MD
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Unterermittler:
- Maxim Itkin, MD
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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
|
|
Experimental: 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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
FTHA transit time
Zeitfenster: 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.
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4 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Dosimetry
Zeitfenster: 4 weeks
|
Calculation of radiation dosimetry from FTHA for whole body and individual organs will be completed.
|
4 weeks
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 857341
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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