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

University College London (UCL)

Status and phase: Enrolling; Phase 2

Conditions: Cancer; Tumor, Solid

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04717674

135083

Details and patient eligibility

About

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

Full description

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.

Enrollment: 21 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

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

Procedure: PET/CT