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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-07

Study Completion Date

2024-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Pilot, Open-label Study of 18F-Fluciclatide PET/CT Imaging in the Evaluation of Anti-angiogenic Therapy in Solid Tumors

NCT01176500

Colon Cancer Lung Cancer Cervical Cancer +2 more

WITHDRAWN PHASE1/PHASE2

Measuring Fatty Acid Oxidation in Cerebral Metastases Using [18F]FPIA

NCT04807582

Cerebral Metastases

COMPLETED

Measuring Treatment Response in Metastatic Renal Cell Cancer Using FPIA PET/CT

NCT04802824

Metastatic Renal Cell Carcinoma

COMPLETED

[18]F-FAZA PET Imaging Study in Patients With Cancer of the Head & Neck, Lung, Renal Cell, Brain, Lymphoma and Neuroendocrine Tumours

NCT00323076

Renal Cell Carcinoma Neuroendocrine Tumours

TERMINATED PHASE1/PHASE2

18F-AlF-FAPi-04 PET/CT Imaging in Patients With Solid Tumor

NCT06126705

Tumor, Solid

RECRUITING EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Cancers have increased energy demands to allow for their rapid growth compared to healthy cells. Glucose is the main source of energy for many cells in the body, and clinicians routinely use a scan which looks at glucose metabolism to assess if cancer treatment is working. However, some cancer cells can create energy to survive and grow in a different way, using fatty acids. In this study, the investigators are using a PET/CT scan to look at a variety of cancer types to see which cancers use fatty acids for energy and if this can be measured. The PET/CT scan will be carried out twice on 2 separate visits so that the investigators can check that both scans give the same result.

The investigators will also carry out special tests on the tumour tissue taken during routine cancer surgery. These tests will look for specific substances in the cancer cells that are related to cancer biology and growth. The investigators will then compare the results from the surgical tissue to the results of the scan to see if there is a relationship between them.

The study will look at 21 patients with solid tumours conducted in 4 NCITA accredited centres, which have different strengths in recruiting specific patient/tumour-type cohorts. Each patient will have two scan visits (between 2-15 days apart) prior to any new treatment starting to check that the scan measurements are repeatable.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Tumor, Solid

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

\[18F\]FPIA radiotracer administration

PET/CT

Intervention Type PROCEDURE

PET/CT scan

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

\[18F\]FPIA radiotracer administration

Intervention Type DRUG

PET/CT

PET/CT scan

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

None are used.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with radiological evidence of solid primary or metastatic target tumour lesions and the following characteristics will be recruited:

1. Age ≥18 years of age
2. Radiologically confirmed tumour size ≥15mm (at least one lesion must be extra-hepatic)
3. The participant is due to undergo surgery within 3 months of the first \[18F\]FPIA PET/CT
4. There is time to complete the two research PET studies without any delay to surgery
5. WHO performance status 0 -2
6. 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
7. The participant is able and willing to comply with study procedures, and signed and dated informed consent is obtained.
8. eGFR of ≥30 within 3 months of \[18F\]FPIA injection.
9. The participant is not scheduled to start cancer treatment (e.g. chemotherapy, radiotherapy, biological therapy or immunotherapy) within the study scanning period.

Exclusion Criteria

* 1\. 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.

2\. 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.

4\. Participants with claustrophobia or who are unable to comfortably tolerate the scanning procedure.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No