68Ga-FAPI-46 PET for imaging of gastrointestinal cancers: A prospective interventional single-arm clinical trial (FAPI-PET-GI)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsklinikum Essen AöR

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify

Decision date (initial)

2025-03-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To evaluate the validity of 68Ga-FAPI-46 PET (positron emission tomography) inter- and intraindividual in patients with gastrointestinal cancers

Secondary objectives 4

1. To assess the accuracy regarding detection of gastrointestinal cancers of 68Ga-FAPI-46-PET
2. To assess the impact on treatment management
3. To validate a correlation between histopathological FAP expression and 68Ga-FAPI-46 uptake intensity
4. To assess the safety of a single imaging dose of 68Ga-FAPI-46 administered as an intravenous bolus injection

Conditions and MedDRA coding

Gastrointestinal cancers (including hepatocellular carcinoma, cholangiocarcinoma, gastric cancers, pancreatic cancer, colorectal cancer and oesophageal cancer)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Proven or suspected gastrointestinal cancers including: - Hepatocellular carcinoma - Cholangiocarcinoma - Gastric cancer - Pancreatic cancer - Colorectal cancer - Oesophageal cancer
2. At initial staging or re-staging of disease
3. At least one detectable tumour lesion with any diameter > 1cm
4. Intended or performed surgery of biopsy of tumor within 8 weeks before or 8 weeks after enrollment and participants consent to utilise biopsy/tumour specimen for immunohistochemical analysis of FAP expression
5. Age ≥ 18 years
6. Participant Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
7. Women of child bearing potential (WOCBP), defines as all women physiologically capable of becoming pregnant, can only be included after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test within 24 hours before radiopharmaceutical application

Exclusion criteria 12

1. Participant cannot give consent for the study
2. Participant can not lie flat or tolerate 68Ga-FAPI-46 PET imaging
3. Prior external beam radiation therapy (EBRT) within 1 month of enrolment to tumour lesions intended for surgery or biopsy
4. Prior chemotherapy, immunotherapy, biologic or targeted oncologic therapy within 1 month prior 68Ga-FAPI-46 PET
5. Unwillingness or inability to comply with study and follow-up procedures
6. History of disease or condition that may critically interfere with participation in this study at the discretion of the investigators
7. Pregnant, lactating, or breast-feeding women
8. Women of child bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, are not allowed to participate in this study, unless they are using highly effective methods of contraception during the interventional period. Highly effective contraception methods include: • True sexual abstinence: defined as refraining from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to IMP, and withdrawal are not acceptable methods of contraception.• Vasectomised partner is a highly effective birth control method if the partner is the sole sexual partner of the study participant and the vasectomised partner has received medical assessment of the surgical success. • Bilateral tubal occlusion. • Combined (oestrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: - oral - intravaginal - transdermal• Progestogen-only hormonal contraception associated with inhibition of ovulation: - oral - injectable - implantable • Placement of an intrauterine device or intrauterine hormone-releasing system
9. Post-menopausal women are allowed to participate in this study. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms), or six months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40mIU/mL or have had surgical bilateral oophorectomy or bilateral salpingectomy or hysterectomy or tubal ligation at least six weeks prior to screening. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
10. Sexually active males must use a condom during intercourse during the interventional period. A condom is required to be used also by vasectomized men in order to prevent delivery of the study compound via seminal fluid
11. QTcF >470 msec for females and QTcF >450 msec for males on screening ECG or history of congenital long QT syndrome
12. Known or expected hypersensitivity to 68Ga-68-FAPI-46 or any of the relevant excipients

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Positive predictive value (PPV) on a per-region- and per-patient-basis of 68Ga-FAPI-46 PET for detection of gastrointestinal cancers, confirmed by histopathology/ biopsy (reached for ≥ 75%)

Secondary endpoints 8

1. Sensitivity and specificity of 68Ga-FAPI-46 PET on a per-patient and per-region-basis for detection of gastrointestinal cancers confirmed by histopathology/ biopsy (separate for regional, extra-regional and distant locations)
2. Detection rate of 68Ga-FAPI-46 PET versus previous standard imaging on a per-patient and per-region basis for detection of tumour location, also stratified by tumour marker serum level
3. Sensitivity and specificity of 68Ga-FAPI-46 PET versus previous standard imaging on a per-patient and per-region-basis for detection of tumour lesions confirmed by combined histopathology/ biopsy/ follow-up imaging/ clinical follow-up reference standard (separate for regional, extra-regional and distant locations
4. Inter-reader reproducibility
5. Impact on therapy management will be evaluated by pre- & post-imaging questionnaires sent to the treating physicians
6. Change in staging/ prognostic groups
7. Association between 68Ga-FAPI-46 PET uptake intensity and histopathologic FAP expression
8. Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) including vital signs and changes in laboratory parameters

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsklinikum Essen AöR

Sponsor organisation

Universitaetsklinikum Essen AöR

Address

Hufelandstrasse 55, Holsterhausen Holsterhausen

City

Essen

Postcode

45147

Country

Germany

Scientific contact point

Organisation

Universitaetsklinikum Essen AöR

Contact name

Wolfgang Fendler

Public contact point

Organisation

Universitaetsklinikum Essen AöR

Contact name

Studienzentrum GmbH

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications