18F-FluorThanatrace (PET/CT) in Glioblastoma

NCT04221061 | Terminated Early Phase 1 DMC FDA Drug

• 1 other identifier: 833963
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The subject will be a candidate for this imaging study because they have agreed to participate in a treatment study involving TTFields (Optune device), a device that uses low intensity, wave like electrical fields, and a PARP inhibitor drug (niraparib). The research study is being conducted to test how a new radioactive imaging drug called 18F-Fluorthanatrace (18F-FTT) can be used to image sites of recurrent brain cancer before or after new treatment or surgery. 18F-FTT is a drug used with an imaging test called Positron Emission Tomography/Computed Tomography (PET/CT).

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Evaluate uptake of [18F]FTT in recurrent glioblastoma after initiation of TTFields therapy.

  Evaluate uptake of \[18F\]FTT in recurrent glioblastoma after initiation of TTFields therapy.

  3 years

Secondary Outcomes (1)

• Correlate [18F]FTT uptake measures with Homologous recombination deficiency (HRD) status or other markers of "BRCAness".

  3 years

Study Arms (2)

Non-surgical candidates

OTHER

In this arm, subjects that do not have a clinical indication for surgical resection of the recurrent tumor will start TTFields therapy 5-7 days prior to starting oral niraparib (a PARP inhibitor).

Drug: 18F-FluorThanatrace

Surgical candidates

OTHER

In this arm, subjects who have a clinical indication for surgical resection of the recurrent tumor will receive TTFields therapy for 5-7 days prior to planned surgical resection, undergo resection, and then resume TTFields therapy and initiate niraparib post-operatively.

Drug: 18F-FluorThanatrace

Interventions

18F-FluorThanatrace DRUG

18F-FluorThanatrace is a novel radiopharmaceutical which measure PARP-1 expression using a Positron Emission Tomography (PET/CT) scan.

Also known as: FTT

Non-surgical candidates; Surgical candidates

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be ≥ 22 years of age
• Participants will have a diagnosis of glioblastoma and be enrolled in the companion treatment trial, IRB 832694.
• Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

You may not qualify if:

• Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of childbearing potential at screening.
• Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
• Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Austin R Pantel, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 9, 2020
• Study Start: February 20, 2020
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

US (1)