[18F]FPIA PET/CT Imaging in Patients With Solid Tumours

NCT04717674 | Unknown Phase 2

• 1 other identifier: 135083
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

Brief Summary

The study will be a phase 2, open-label study in patients with solid tumours to explore the relationship between short-chain fatty acid uptake using \[18F\]FPIA PET/CT and tumour proliferation

Conditions

Cancer; Tumor, Solid

Outcome Measures

Primary Outcomes (1)

• The relationship between [18F]FPIA uptake and percent positive tumour cells reported as counts defined per area from whole section immunohistochemistry for PHH3.

  To explore the relationship between short-chain fatty acid uptake using \[18F\]FPIA PET/CT and tumour proliferation in patients with solid tumours.

  6 months

Secondary Outcomes (4)

• Estimation of SUVmax of target lesions at 30 minutes and 60 min.

  60 min

• Estimation of tumour-to-background ratio of target lesions at 30 minutes and 60 min.

  60 min

• Graphical presentation and reliability of repeat semi-quantitative measure (SUV) of target lesions between two PET scans for each time point (30 min and 60 min). Bland Altman and ICC will be presented.

  15 days

• Graphical presentation of [18F]FPIA uptake and whole section immunohistochemistry for Ki-67 and mitotic count (mitoses per mm2) assessed on hematoxylin and eosin (H&E) sections. Pearson's correlation coefficient will be reported.

  6 months

Other Outcomes (1)

• To explore the relationship between [18F]FPIA tumour uptake and histological markers of tumour metabolism.

  6 months

Study Arms (1)

Drug: [18F]Fluoropivalate ([18F]Fluoro-2,2-Dimethylpropionic Acid) (FPIA)

EXPERIMENTAL

Participants will undergo two PET/CT scans with the tracer \[18F\]Fluoropivalate (\[18F\]Fluoro-2,2-Dimethylpropionic Acid) (FPIA), referred to as \[18F\]FPIA, on 2 separate visits.

Drug: [18F]Fluoropivalate ([18F]Fluoro-2,2-Dimethylpropionic Acid); Procedure: PET/CT

Interventions

[18F]Fluoropivalate ([18F]Fluoro-2,2-Dimethylpropionic Acid) DRUG

\[18F\]FPIA radiotracer administration

Also known as: None are used.

Drug: [18F]Fluoropivalate ([18F]Fluoro-2,2-Dimethylpropionic Acid) (FPIA)

PET/CT PROCEDURE

PET/CT scan

Drug: [18F]Fluoropivalate ([18F]Fluoro-2,2-Dimethylpropionic Acid) (FPIA)

Eligibility Criteria

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

You may qualify if:

• Patients with radiological evidence of solid primary or metastatic target tumour lesions and the following characteristics will be recruited:
• Age ≥18 years of age
• Radiologically confirmed tumour size ≥15mm (at least one lesion must be extra-hepatic)
• The participant is due to undergo surgery within 3 months of the first \[18F\]FPIA PET/CT
• There is time to complete the two research PET studies without any delay to surgery
• WHO performance status 0 -2
• If female, the participant is either post-menopausal (\>1 year), or surgically sterilised (has had a documented bilateral oophorectomy and/or documented hysterectomy, \>2 years), or if of childbearing potential, must have a negative urine pregnancy test within 2 hours prior to injection of imaging agent
• The participant is able and willing to comply with study procedures, and signed and dated informed consent is obtained.
• eGFR of ≥30 within 3 months of \[18F\]FPIA injection.
• The participant is not scheduled to start cancer treatment (e.g. chemotherapy, radiotherapy, biological therapy or immunotherapy) within the study scanning period.

You may not qualify if:

• \. The participant has received chemotherapy, immunotherapy, biologic therapy or investigational therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of \[18F\]FPIA injection or is due neoadjuvant therapy between the PET and surgery.
• \. The participant is pregnant or lactating. 3. The participant is scheduled to have a nuclear medicine or contrast scan within 24 hours before the administration of \[18F\]FPIA.
• \. Participants with claustrophobia or who are unable to comfortably tolerate the scanning procedure.

Sponsors & Collaborators

• University College, London: lead
• Cancer Research UK: collaborator
• Imperial College London: collaborator
• National Cancer Imaging Translational Accelerator: collaborator

Study Sites (3)

Guy's & St. Thomas' NHS Foundation Trust

London, United Kingdom

RECRUITING

Imperial College Healthcare NHS Trust

London, United Kingdom

RECRUITING

The Royal Marsden NHS Foundation Trust

London, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Tara Barwick

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura McLeavy

CONTACT

0203 313 3720; ncita.fpia@ucl.ac.uk

Tara Barwick

CONTACT

tara.barwick@nhs.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 22, 2021
• Study Start: December 7, 2021
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 3, 2023

Record last verified: 2023-10

Locations

GB (3)