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PET/CT imaging with [18F]CTT1057 followed by [68Ga]Ga-PSMA-11 or vice versa for Recurrence (GuidePath Trial)

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization up to 14 days after obtaining the results of the [18f]ctt1057 pet imaging
Awards & highlights

GuidePath Trial Summary

This trial will test a new imaging agent to detect and localize prostate cancer recurrence in 190 people.

Eligible Conditions
  • Recurrence
  • Prostate Cancer

GuidePath Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization up to 14 days after obtaining the results of the [18f]ctt1057 pet imaging
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization up to 14 days after obtaining the results of the [18f]ctt1057 pet imaging for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient-level positive predictive value (PPV) (with anatomical localization) of [18F]CTT1057
Region-level correct localization rate (CLR) of [18F]CTT1057
Secondary outcome measures
PET/CT scan
Characterize the safety and tolerability of [18F]CTT1057
Concordance between [18F]CTT1057 and [68Ga]Ga-PSMA-11 for detection of lesions at lesion level using central reads
+13 more

GuidePath Trial Design

1Treatment groups
Experimental Treatment
Group I: PET/CT imaging with [18F]CTT1057 followed by [68Ga]Ga-PSMA-11 or vice versaExperimental Treatment2 Interventions
All eligible participants will be assigned to one of the following two PET/CT scan sequences at random in a 1:1 ratio: Sequence 1: [18F]CTT1057 on Day 1 (investigational imaging agent of interest) followed by [68Ga]Ga-PSMA-11 at least 14 days apart (as part of CTS if required, and for secondary endpoint) Sequence 2: [68Ga]Ga-PSMA-11 (as part of CTS if required, and for secondary endpoint) on Day 1 followed by [18F]CTT1057 (investigational imaging agent of interest) at least 14 days apart
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
[18F]CTT1057
2021
Completed Phase 3
~370
[68Ga]Ga-PSMA-11
2021
Completed Phase 3
~180

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,857 Previous Clinical Trials
4,197,621 Total Patients Enrolled
21 Trials studying Recurrence
1,361 Patients Enrolled for Recurrence

Media Library

PET/CT imaging with [18F]CTT1057 followed by [68Ga]Ga-PSMA-11 or vice versa Clinical Trial Eligibility Overview. Trial Name: NCT04838613 — Phase 3
Recurrence Research Study Groups: PET/CT imaging with [18F]CTT1057 followed by [68Ga]Ga-PSMA-11 or vice versa
Recurrence Clinical Trial 2023: PET/CT imaging with [18F]CTT1057 followed by [68Ga]Ga-PSMA-11 or vice versa Highlights & Side Effects. Trial Name: NCT04838613 — Phase 3
PET/CT imaging with [18F]CTT1057 followed by [68Ga]Ga-PSMA-11 or vice versa 2023 Treatment Timeline for Medical Study. Trial Name: NCT04838613 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open at the moment for this medical investigation?

"According to the details shared on clinicaltrials.gov, this medical trial is actively seeking volunteers and has been since September 30th 2021. The study was last updated on March 2nd 2023."

Answered by AI

What is the current capacity for patient recruitment in this experiment?

"Affirmative. According to the details on clinicaltrials.gov, this medical trial is currently enrolling participants as of March 2nd 2023 and was first posted on September 30th 2021. The researchers seek 190 volunteers from 9 sites for their study."

Answered by AI

Is the FDA-endorsed sequence of PET/CT imaging with [18F]CTT1057 followed by [68Ga]Ga-PSMA-11 or vice versa?

"Our team has assigned PET/CT imaging with [18F]CTT1057 followed by [68Ga]Ga-PSMA-11 or vice versa a rating of 3 due to the pre-existing evidence that supports efficacy and safety."

Answered by AI

In what geographical areas is this research endeavor taking place?

"Currently, this medical trial is seeking participants from 9 locations across Europe. These sites are situated in Nimes Cedex 9, Barcelona and Marseille Cedex 05 as well as 6 other areas. To reduce the need for travel when participating in the study, it is wise to select a site close by your residence."

Answered by AI

Are there any prior experiments that have examined the combination of [18F]CTT1057 and [68Ga]Ga-PSMA-11 imaging with PET/CT?

"Radiotracer PET/CT imaging with [18F]CTT1057 followed by [68Ga]Ga-PSMA-11 or the inverse was first explored in 2021 at Novartis Investigative Site, resulting in 3 completed trials. Currently, 2 additional experiments are taking place largely from Nimes Cedex 9 and Barcelona."

Answered by AI

Is this an innovative or groundbreaking trial?

"Currently, two experiments investigating PET/CT imaging with [18F]CTT1057 followed by [68Ga]Ga-PSMA-11 or vice versa are under way across 5 countries and 6 cities. The primary trial, sponsored by Novartis Pharmaceuticals in 2021 involved 195 participants and achieved Phase 2 & 3 drug approval. Subsequent to the initial study's completion, three additional trials have been conducted since then."

Answered by AI

What is the ultimate aim of this experiment?

"This trial will assess the Patient-level positive predictive value (PPV) & accuracy of [18F]CTT1057 as measured by a PET imaging scan at either Day 1 or 15 and Composite Truth Standard (CTS). Additionally, intra-reader variability in the scans' results, patient-level PPV related to PSA levels will be evaluated. The efficacy analysis set consists of individuals who have previously undergone Radical Prostatectomy or curative intent Radiation Therapy (RT), all with their data stratified according to respective PSA levels."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Diagnostic Performance of [18F]CTT1057 in BCR
2021. "Study of Diagnostic Performance of [18F]CTT1057 in BCR". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04838613.
~51 spots leftby Apr 2025
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