AzTrials
AzTrials

Prostatic NeoplasmsPhase 2/3GuideViewNCT04838626

Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection

A Phase 2/3 study testing [18F]CTT1057 in people with Prostatic Neoplasms and Prostate Cancer, run by Novartis Pharmaceuticals at 16 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study was to evaluate the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of PSMA positive tumors using histopathology as Standard of Truth (SoT). Read more about this study

Who is it for?
Ages 18 to 100 years, men only
Conditions the study is for
Prostatic Neoplasms, Prostate Cancer
What is being tested?
[18F]CTT1057
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
195 participants
Where
16 sitesin 5 countries
Study dates
7 Sep 2021to 24 Nov 2023
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Untreated high risk biopsy-proven PCa patients according to D'Amico classification (Stage ≥ T2c or PSA level >20ng/ml or Gleason score ≥8) (D'Amico et al 1998)
  • Scheduled or planned radical prostatectomy and extended pelvic lymph node resection up to 6 weeks after the investigational PET/CT scan followed by histopathology assessment
  • ECOG performance status 0-2
  • Signed informed consent must be obtained prior to participation in the study
  • Participants must be adults ≥ 18 years of age

Who cannot join

  • Inability to complete the needed investigational and standard-of-care imaging examinations due to any reason (severe claustrophobia, inability to lie still for the entire imaging time, etc.)
  • Any additional medical condition, serious intercurrent illness, concomitant cancer or other extenuating circumstance that, in the opinion of the Investigator, would indicate a significant risk to safety or impair study participation, including, but not limited to, current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, need of indwelling/condom catheters, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, and COVID-19.
  • Known allergy, hypersensitivity, or intolerance to [18F]CTT1057
  • Prior and current use of PSMA targeted therapies
  • Prior and current treatment with any ADT (first or second generation), including LHRH analogues (agonists or antagonists)
  • Any 5-alpha reductase inhibitors within 30 days before screening
Show all 9Show fewer
  • Patients with small cell or neuroendocrine PCa in more than 50% of biopsy tissue
  • Patients with incidental PCa after transurethral resection
  • Use of other investigational drugs within 30 days before screening

Trial locations and contacts

16 sites in 5 countries.

16 sites in 5 countries

France5 sites

  • Novartis Investigative Site

    Marseille, 13273

  • Novartis Investigative Site

    Nîmes, 30029

  • Novartis Investigative Site

    Pierre-Bénite, 69495

  • Novartis Investigative Site

    Toulouse, 31054

  • Novartis Investigative Site

    Toulouse, 31059

Other trials in France

Italy5 sites

  • Novartis Investigative Site

    Bergamo, BG, 24127

  • Novartis Investigative Site

    Milan, MI, 20132

  • Novartis Investigative Site

    Milan, MI, 20141

  • Novartis Investigative Site

    Milan, MI, 20162

  • Novartis Investigative Site

    Rozzano, MI, 20089

Other trials in Italy

Spain3 sites

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Barcelona, 08036

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907

Other trials in Spain

Switzerland2 sites

  • Novartis Investigative Site

    Bellinzona, 6500

  • Novartis Investigative Site

    Geneva, 1211

Other trials in Switzerland

United States1 site

  • Explorer Molecular Imaging center

    Sacramento, California, 95816

Other trials in United States

About this study

Official title: Phase II/III Study for Evaluation of the Diagnostic Performance of [18F]CTT1057 PET Imaging for the Detection of PSMA Positive Tumors Using Histopathology as a Standard of Truth

The purpose of this study was to evaluate the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of PSMA positive tumors using histopathology as Standard of Truth (SoT). Tissue specimens from both the primary tumor and pelvic lymph nodes dissected during surgery from patients with newly-diagnosed high-risk prostate cancer (PCa) were used for the histopathology assessments.

Read the detailed description

This was a multi-center, single-arm, open-label prospective study to evaluate the diagnostic performance of vidoflufolastat (18F) as a positron emission tomography (PET) imaging agent for detection and localization of prostate specific membrane antigen (PSMA) positive tumors, using histopathology as standard of truth (SoT). in newly diagnosed high-risk prostate cancer (PCa) patients.

A total of 195 participants were enrolled to ensure that at least 156 participants were evaluable for the co-primary endpoints. Surgery was performed after vidoflufolastat (18F) positron emission tomography/computerized tomography (PET/CT) scan.

The co-primary endpoints of patient-level sensitivity and region-level specificity were assessed by comparing the central reading results of the vidoflufolastat (18F) PET/CT scan to the local histopathology results in the dissected tissue specimens, i.e. both the primary tumor and the dissected Pelvic Lymph Nodes (PLNs).

Being tested
[18F]CTT1057
Keywords
[18F]CTT1057, Positron Emission Tomography/Computerized Tomography, PET/CT, Radioligand, Imaging, Primary Staging, PS, Standard of Truth, SoT, Prostate Cancer, PCa
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]CTT1057Drug

    Also called Single intravenous dose of approximately 370 Mega-Becquerel (MBq) and subsequent PET/CT scan

    PET/CT imaging with [18F]CTT1057

Study groups in NCT04838626
Study groupRoleWhat they receive
PET/CT imaging with [18F]CTT1057ExperimentalAll eligible participants will be enrolled to receive [18F]CTT1057 imaging agent on Day 1 and have PET/CT scan
Receives: Drug: [18F]CTT1057

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient-level Sensitivity of Vidoflufolastat (18F) - % Sensitivity

    Sensitivity of vidoflufolastat (18F) Positron Emission Tomography (PET) imaging, considering Prostate Specific Membrane Antigen (PSMA) positive patients as those who show at least one pathological vidoflufolastat (18F) uptake either in the primary tumor and/or metastatic Pelvic Lymph Node (PLN) regions, with anatomically localized correspondence with the Standard of Truth (SoT).

    Measured: vidoflufolastat (18F)7 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

  2. Region-level Specificity of Vidoflufolastat (18F) - % Specificity

    Specificity of vidoflufolastat (18F) PET imaging, defined as proportion of PLN regions that test negative for lymph nodes on vidoflufolastat (18F) among those that are lymph node negative on the SoT.

    Measured: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

Secondary outcomes (22)

  1. Patient-level Specificity of Vidoflufolastat (18F) - % Specificity

    Specificity of vidoflufolastat (18F) PET imaging, considering PSMA negative patients as those who do not show any pathological vidoflufolastat (18F) uptake either in the primary tumor or PLNs and will be confirmed not having primary tumor or metastatic PLNs with the SoT

    Measured: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

  2. Patient-level Positive Predictive Value of Vidoflufolastat (18F)

    Proportion of patients who are both vidoflufolastat (18F) and SoT positive (true positives (TP) among those who test positive on vidoflufolastat (18F) (TP+ false positives (FP))

    Measured: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

  3. Patient-level Negative Predictive Value of Vidoflufolastat (18F)

    Proportion of patients who are both vidoflufolastat (18F) and SoT negative (true negatives (TN)) among those who test negative on vidoflufolastat (18F) (TN+ false negatives (FN))

    Measured: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

  4. Patient-level Accuracy of Vidoflufolastat (18F)

    Proportion of patients that are SoT and vidoflufolastat (18F) positive (TP) and negative (TN) among all patients in Efficacy Analysis Set (EFF) (TP+TN+FP+FN)

    Measured: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

  5. Region-level Sensitivity of Vidoflufolastat (18F) - % Sensitivity

    Proportion of PLN regions that test positive on both vidoflufolastat (18F) and SoT (TP) among those that are SoT positive (TP+FN)

    Measured: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

  6. Region-level Positive Predictive Value of Vidoflufolastat (18F)

    Proportion of Pelvic Lymph Node (PLN) regions that are Standard of Truth (SoT) and vidoflufolastat (18F) positive (TP) among those regions that test positive on vidoflufolastat (18F) (TP+False Positive (FP))

    Measured: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

  7. Region-level Negative Predictive Value of Vidoflufolastat (18F)

    Proportion of PLN regions that are SoT and vidoflufolastat (18F) negative (TN) among those regions that test negative on vidoflufolastat (18F) (TN+FN)

    Measured: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

  8. Region-level Accuracy of Vidoflufolastat (18F)

    Proportion of PLN regions that are SoT and vidoflufolastat (18F) positive (TP) and negative (TN) among all PLN regions assessed vidoflufolastat (18F)(TP+TN+FP+FN)

    Measured: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

  9. Region-level Sensitivity of Vidoflufolastat (18F) Scan With Standard of Truth Excluding Pelvic Lymph Node (PLN) Metastasis < 2 mm

    Sensitivity of vidoflufolastat (18F) PET imaging in the PLN region, excluding from the analysis those lymph nodes showing metastasis <2mm (micro-metastasis)

    Measured: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

  10. Detection of Distant Metastasis of Vidoflufolastat (18F) Scan - Participants With at Least One Distant Metastatic Lesion (%)

    Number of distant metastasis identified at PET/CT scan in all patients, and percentage of patients with at least one distant metastatic lesion (extra-PLN, visceral or skeletal)identified by PET scan in all patients with an evaluable vidoflufolastat (18F) PET/CT scan.

    Measured: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

  11. Overview of Adverse Events

    An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject

    Measured: Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.

  12. Vidoflufolastat (18F) Scan Inter-reader Variability - %

    Scan inter-reader variability is defined the agreement rate among reader determination of vidoflufolastat (18F) images.

    Measured: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

  13. Vidoflufolastat (18F) Scan Inter-reader Variability - Number of Scans Agreed

    Scan inter-reader variability is defined the agreement rate among reader determination of vidoflufolastat (18F) images.

    Measured: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

  14. Vidoflufolastat (18F) Scan Intra-reader Variability

    Scan intra-reader variability is defined as the within-reader agreement rate of vidoflufolastat (18F) images.

    Measured: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

  15. Observed Maximum Blood Concentration (Cmax) of Vidoflufolastat (18F)

    Measured: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)

  16. Time of Maximum Observed Blood Concentration Occurrence (Tmax) of Vidoflufolastat (18F)

    Measured: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)

  17. Area Under the Vidoflufolastat (18F) Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast)

    Measured: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)

  18. Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf) of Vidoflufolastat (18F)

    Measured: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post infusion)

  19. Half-Life Lambda z of Vidoflufolastat (18F)

    Measured: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)

  20. Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) of Vidoflufolastat (18F)

    Measured: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)

  21. Urinary Excretion of Radioactivity Expressed as a Percentage of Injected Activity (%IA) of Vidoflufolastat (18F)

    Measured: Day 1 (pre-injection/0 hour, 0 hour (injection) - T (image acquisition starting time), T (image acquisition starting time) to 3 hours, 3 hours to 5 hours post imaging)

  22. Total Systemic Clearance for Intravenous Administration (CL) of Vidoflufolastat (18F)

    Measured: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2021
  2. Study start7 Sep 2021
  3. Primary completion24 Nov 2023
  4. Study completion24 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
All participants will receive \[18F\]CTT1057 for PET/CT scan imaging, and surgery will be performed up to 6 weeks after \[18F\]CTT1057 PET for pathology assessment of the tissue specimens. Additional pharmacokinetics (PK) assessments will be performed on the date of imaging in a subset of approximately 10 patients at the same site.
Masking
None (open label)
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04838626
Sponsor's protocol ID
CAAA405A12302
Other IDs
2020-003958-67
Acronym
GuideView
Status last verified
Sep 2025
First submitted
7 Apr 2021
Last updated
7 Oct 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Iagaru A, Suarez JF, Behr S, Aggarwal R, Paredes P, Buffi N, Penhoat T, Ceci F, Walz J, Doumerc N, Coulanges M, Xu Z, Seigne C, Wilke C, Catafau AM, Fanti S, Maurer T; GuideView study investigators. Imaging Efficacy of [18F]CTT1057 PET for the Detection of PSMA-Positive Tumors Using Histopathology as Standard of Truth: Results from the GuideView Phase 2/3 Prospective Multicenter Study. J Nucl Med. 2025 Aug 1;66(8):1232-1238. doi: 10.2967/jnumed.124.269007.

    PubMed 40473463

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing [18F]CTT1057 in people with Prostatic Neoplasms and Prostate Cancer, run by Novartis Pharmaceuticals at 16 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France, Italy, Spain, Switzerland, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-level Sensitivity of Vidoflufolastat (18F) - % Sensitivity (time frame: vidoflufolastat (18F)7 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04838626, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in