This study has been transitioned to CTIS with ID 2024-516486-36-00 check the CTIS register for the current data. Part A: To acquire an optimal pharmacokinetic model of [68Ga]Ga-FAPI-46 by which simplified methods to quantify [68Ga]Ga-FAPI-46 PET…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Hepatobiliary neoplasms malignant and unspecified
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part A: Pharmacokinetic analysis
1. To identify the optimal kinetic model to quantify [68Ga]Ga-FAPI-46
pharmacokinetics and tracer uptake.
2. To identify the most suitable simplified quantitative measurement as a
surrogate for the full kinetic model.
Part B: Test-retest variation study
1. The daily variability (average percentage of difference) of the preferred
simplified method for quantification of [68Ga]Ga-FAPI-46.
Part C: Diagnostic accuracy
1. Per lesion analysis of diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT .
2. Diagnostic accuracy of response monitoring using [68Ga]Ga-FAPI-46 PET/CT.
Secondary outcome
Part C:
1. Percentage of agreement between tumor uptake on the [68Ga]Ga-FAPI-46 PET/CT
scan, histopathologic evidence of tumor, and the expression of FAP (IHC).
2. Percentage of potential change of therapy management enabled by
[68Ga]Ga-FAPI-46 PET/CT.
3. Percentage of agreement between different imaging modalities
([68Ga]Ga-FAPI-46 PET/CT and CT, MRI or FDG PET/CT).
4. Sensitivity of response prediction based on the first [68Ga]Ga-FAPI-46
PET/CT.
5. Accuracy of determining surgical resectability using [68Ga]Ga-FAPI-46 PET/CT.
6. Correlation between [68Ga]Ga-FAPI-46 PET/CT signal to tumor regression
(MDACC method).
7. Diagnostic accuracy of incidental findings on [68Ga]Ga-FAPI-46 PET/CT.
Background summary
Pancreaticobiliary cancer patients have a dismal prognosis. Therefore, patient
stratification for the proper primary treatment is crucial to prevent
unnecessary surgery and open up the opportunity for novel (multimodal)
treatment. Unfortunately, conventional imaging modalities are not sensitive
enough to detect small tumor lesions or differentiate between benign and
tumorous tissue. Tumor-specific imaging, using PET/CT imaging, can identify
tumor tissue in a specific manner and therefore improve lesion detection and
patient stratification. Fibroblast activation protein (FAP) shows promise as a
target to identify pancreaticobiliary cancers, tumor-positive lymph nodes, and
residual disease after neoadjuvant therapy. The FAP targeted inhibitor (FAPI)
is developed to target FAP and has been labelled to the Gallium-68 (68Ga)
radioisotope, resulting in the [68Ga]Ga-FAPI-46 tracer.
This study will be a three part single center study resulting in the clinical
evaluation of [68Ga]Ga-FAPI-46. In Part A, the pharmacokinetics of this tracer
will be studied and the simplified methods to quantify tracer uptake will be
validated. Part B will comprise a test-retest study to assess the repeatability
of these simplified quantitative methods. In part C, the sensitivity and
feasibility of therapy response monitoring will be investigated.
Study objective
This study has been transitioned to CTIS with ID 2024-516486-36-00 check the CTIS register for the current data.
Part A: To acquire an optimal pharmacokinetic model of [68Ga]Ga-FAPI-46 by
which simplified methods to quantify [68Ga]Ga-FAPI-46 PET signal will be
validated.
Part B: To determine the test-retest repeatability of the quantitative
measurements (as derived from Part A).
Part C:
1. To determine the diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT to detect
pancreatic cancer lesions.
2. To determine the sensitivity of response monitoring using [68Ga]Ga-FAPI-46
PET/CT.
Study design
This study is a single center three part study for the evaluation of
[68Ga]Ga-FAPI-46 PET/CT. It is a non-randomized, non-blinded, prospective
observational study. The sample size is based on assessing diagnostic
sensitivity and sensitivity for response monitoring, and will include a maximum
of 63 (18+13+32) evaluable patients.
Study burden and risks
The burden of participation in this study is dependent on the study phase. In
part A, this burden consists of two venous and one arterial cannula, the
injection of the radioactive [68Ga]Ga-FAPI-46 tracer (radiation burden and risk
of allergic reaction), approximately spending 120 minutes in the scanner and
one extra hospital visit (3 hours in total). Dependent on the results from part
A, study procedures will be simplified where possible in part B and C. For
these parts the burden consists of two extra hospital visits (estimated at a
total of 3 hours), two times a venous cannula and two times the injection of
the radioactive [68Ga]Ga-FAPI-46 tracer (radiation burden and risk of allergic
reaction). The total duration of the scan will be based on the results of part
A. An estimate of the scan duration in part B and C is 20 minutes.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Patients aged 18 years or older.
- Before patient registration, written informed consent must be given according
to ICH/GCP, and national/local regulations.
- Additional Part A: patients with pancreaticobiliary cancer (pancreatic,
intra- or extrahepatic cholangiocarcinoma) and a minimum tumor size of 20mm on
CT.
- Additional Part B: patients with primary pancreatic (or pancreaticobiliary)
cancer (depending on the results of part A) and a minimum tumor size of 20mm on
CT. No treatment may be given in between the two scans.
- Additional Part C: patients with pathologically proven pancreatic ductal
adenocarcinoma, eligible for neoadjuvant therapy before surgical resection.
Exclusion criteria
- Women who are pregnant and/or lactating.
- Medical or psychiatric conditions that compromise the patient*s ability to
give informed consent. Presence of any psychological, familial, sociological or
geographical condition potentially hampering compliance with the study protocol
and follow-up schedule.
- Impaired renal function (creatinine clearance <=60 mL/min according to the
Cockcroft-Gault equation
- Leucocytes (WBC) <=3.0 x 10^9/l
- Platelets <= 100 x 10^9 /l
- Hemoglobin <= 6 mmol/l
- Known hypersensitivity to drugs comparative to [68Ga]Ga-FAPI-46, or any of
the excipients of [68Ga]Ga-FAPI-46.
- Inability to undergo PET/CT scanning (e.g. claustrophobia, weight limits or
inability to tolerate lying for the duration of a PET/CT scan (~90 min).
Additional Part A:
- Contra-indication for arterial cannulation (e.g. inadequate circulation of
extremity, positive Allen test, severe atherosclerosis, coagulant disorder (INR
>1.4 or APTT >50)).
Additional Part C:
- Not eligible for surgery after neoadjuvant chemotherapy.
- If based on the first FAPI-46 PET/CT, there is a suspicion of metastatic
disease the images will be discussed in the multidisciplinary meeting and one
additional imaging modality (and a biopsy, if this would lead to a change of
treatment strategy) can be used to confirm the suspicion. If metastatic disease
is confirmed the patient will be excluded.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-516486-36-00 |
| EudraCT | EUCTR2022-001867-29-NL |
| CCMO | NL81511.018.22 |