Xiao Chen, Ph.D

Jinju Sun, MSc

Cancer associated fibroblasts (CAFs) can promote tumor cell proliferation, migration, invasion, and angiogenesis through immunosuppressive effects and the production of mediators, thereby promoting tumor growth and progression. The characteristic of CAFs is high expression of fibroblast activation protein (FAP). In approximately 90% of epithelial derived tumors, FAP is highly overexpressed on the membrane of CAFs. Contrary to CAFs, FAP expression is lower or absent in normal tissues. Therefore, FAP inhibitors (FAPI) targeting FAP can overcome the limitations of 18F-2-fluoro.2-deoxy-D-glucose fluorodeoxyglucose(18F-FDG) PET imaging. But like 18F-FDG, wound healing, fibrosis, and inflammation can also uptake FAPI.. Therefore, a comparison of the performance of 18F-FDG and 18F-FAPI PET imaging in diagnosing primary and metastatic lesions of various types of cancer is conducted to evaluate the potential value of these new radiopharmaceuticals as effective alternatives to 18F-FDG, highlighting their advantages and limitations.

This study is a prospective, single study and has been approved by the ethics committee. The subjects of this studywere from January 1,2024 to December 31, 2029.The detailed description is as follows:

1. Patients: The subjects we selected are adults who are not restricted by gender. For details, please refer to the "Eligibility Criteria" column.
2. Clinical data collection: Record the course of disease, laboratory tests (tumor markers, inflammatory markers), PET examinations, and follow-up related imaging (ultrasound, CT, or magnetic resonance imaging（MRI）) information of all patients.
3. CT or MRI image analysis: Record the location and number of lesions, measure the long diameter of the primary and metastatic lesions, and the short diameter of lymph nodes on CT or MRI images.
4. PET image analysis: Record and evaluate the following indicators: the maximum, mean and peak standardized uptakevalue (SUVmax, SUVmean and SUVpeak), Metabolic lesion volume (MLV), total lesion glycolysis (TLG).
5. Statistical analysis: Use descriptive statistical methods to compare the age of patients and the standardized uptake values of FDG and FAPI. Normal distribution data is represented as mean ± standard deviation, while non normal distribution data is represented as median with IQR. Compare the normal distribution data between two groups using paired two sample t-test, and compare the non normal distribution data between two groups using McNemar test. Using a four grid table McNemar χ Compare the diagnostic efficacy of 18F-FDG PET and 18F-FAPI PET through 2 tests, calculate and compare the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 18F-FDG and 18F-FAPI PET. Due to the potential impact of tumor type on diagnosis, subgroup analysis was conducted on the diagnostic efficacy of 18F-FDG PET and 18F-FAPI PET. Due to the possibility of multiple metastatic lesions in a given participant, the diagnostic results may be correlated within the participant. Therefore, sensitivity analysis of metastatic lesions is also performed based on a generalized linear mixed effects model by combining this correlation between different lesions within the same participant. Double tailed P\<0.05 indicates a statistically significant difference.

Application of FAPI and FDG PET Imaging in Patients With Different Types of Cancer

The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 18F-FAPI PET were calculated and compared to evaluate the diagnostic efficacy.

Standardized uptake value (SUV) of 18F-FDG and 18F-FAPI for each target lesion of subject or suspected primary tumor or/and metastasis.

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Director of Nuclear Medicine Department

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

a new technology that using Fibroblast activation protein （FAP）inhibitor as the tracer of PET-CT

68Ga-FAPI-PET-CT

JianFa Lan, Doctor

Zhengyi Chen, doctor

A study to discuss the advantage of Fapi PET- CT in the initial diagnosis staging and lesion determination of ovarian cancer,whether it can be a evaluation strategy as an R0 evaluation tool or a prediction tool of chemotherapy response and evaluation of prognosis.

Ovarian cancer is a challenging disease. It is difficult to diagnose early, and the recurrence rate is high after initial treatment. In the past decades, in addition to cancer treatment methods, imaging evaluation has also made corresponding progress. In particular, molecular imaging using FDG-PET / CT has shown a strong role in ovarian cancer. It can locate metabolic changes before anatomical changes, point out small lymph node (LN) metastasis, find distant metastasis and definite recurrence.In terms of diagnosis, several studies have shown that PET-CT is superior to CT in ovarian cancer staging and has obvious advantages in the determination of extraperitoneal metastasis; In terms of predicting whether ro surgery can be performed, there are some mature scoring systems, such as eisenkop,suidan score etc.but there is still no unique scoring mode suitable for PET-CT; Despite the above advantages, the nonspecific uptake mechanism of FDG-PET may lead to false positive results.Cancer associated fibroblasts (CAFs) are one of the factors that independently mediate tumor growth and metastasis. They are also related to extracellular fibrous tissue and tumor size Fibroblast activation protein (FAP) is overexpressed in fibroblasts of many epithelial cancers, but rarely expressed in normal tissues.Therefore, imaging with FAP as a marker is a promising way in many tumor types In our previous study, \[68Ga\] GA dotafapi - PET / CT D compared with \[18F\] - FDG PET / CT has advantages in detecting primary and metastatic lesions of many tumors, especially peritoneal metastatic tumors, such as ovarian cancer.

A Prospective Cohort Study of 68ga-FAPI-pet-ct Versus FDG-pet-ct for Ovarian Cancer

The consistency between the lesions detected by PET CT and those detected during operation (based on pathology)

The First Affiliated Hospital of Xiamen University

Digestive System Diseases

Skin and Connective Tissue Diseases

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Esophageal Neoplasms

Cholangiocarcinoma

Adenocarcinoma

Melanoma

Carcinoma, Squamous Cell

Sarcoma

Ichthyosis, X-Linked

Squamous Cell Carcinoma of Head and Neck

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplasms, Connective and Soft Tissue

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Bile Duct Cancer

Soft Tissue Sarcoma

Neuroendocrine Tumor

Neuroepithelioma

Up to 30 patients with FAP-avid solid tumors.

\[Ga-68\]-PNT6555 IV administered as imaging agent for PET/CT

[Ga-68]-PNT6555

Patients with FAP-avid disease as determined by the \[Ga-68\]-PNT6555 screening PET/CT will receive \[Lu-177\]-PNT6555 at a fixed dose level for up to 6 doses at an interval of 6 weeks between each dose.

[Lu-177]-PNT6555

Jessica Jensen

This Phase 1 study will evaluate the safety and tolerability of \[Ga-68\]-PNT6555 and \[Lu-177\]-PNT6555 in subjects with select solid tumors that have FAP over-expression, in order to determine a recommended Phase 2 dose.

FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients With Select Solid Tumors (FRONTIER)

Objective response rate (ORR) based on RECIST 1.1

Absorbed dose estimates (Gy) in tumor lesions for \[Lu-177\]-PNT6555

\[Ga-68\]-PNT6555 SUV at 0 - 60, 60, 90, and 120 min of tumor lesions and normal organs

Occurrence of Treatment emergent adverse events as per CTCAE v5.0

Occurrence of adverse events for \[Ga-68\]-PNT6555 as per CTCAE v5.0

Absorbed dose estimates (Gy) in normal organs for \[Lu-177\]-PNT6555

Absorbed dose estimates (Gy) in normal organs for \[Ga-68\]-PNT6555

Anatomic distribution of \[Ga-68\]-PNT6555

Maximum and average standardized uptake values of \[Ga-68\]-PNT6555 in tumor lesions

POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Androgen Antagonists

Computed tomography

Antti S Rannikko, MD, PhD

Antti s Rannikko, MD, PhD

Tuomas Mirtti, MD, PhD

Henrikki Santti, MD, PhD

Anssi Petas, MD, PhD

Mika Matikainen, MD, PhD

Tuomas Kilpeläinen, MD, PhD

Teijo Pellinen, PhD

Antti Loimaala, MD, PhD

Oleg Kerro, MD

Kim Bergström, PhD

Teija Koivula, PhD

Antti Rannikko, MD, PhD

The investigators explore the biodistribution of FAPI-PET expression in primary high-risk prostate cancer in men undergoing RALP and eLND and in men with metastatic PCa about to start next generation antiandrogen.

This is an exploratory cohort study comprised of men with clinically localized or locally advanced high-risk prostate cancer (GG 3-5, cT2-cT3, Nx, M0) managed by RALP and eLND and men with metastatic (mHSPC or mCRPC) prostate cancer scheduled to start NHT along clinical care pathway (e.g., apalutamide, enzalutamide) at HUS Helsinki University Hospital and Helsinki University, Finland.

Men identified along routine clinical care as candidates for the study will be asked to consent.

Once consented, patients will undergo PSMA-PET imaging instead of conventional imaging (CT and bone scan) and experimental FAPI-PET imaging. Furthermore, biomarker samples will be obtained before and after treatment (surgery or novel antiandrogen) and surgical specimen will be processed for routine pathological evaluation and multiplex IHC studies. Serum samples will be tested for PCa biomarkers (e.g., PSA, NSE, CgA) and cfDNA. Urine will be processed and extracellular vesicles (exosomes) isolated and markers of reactive stroma will be sought for.

Radical prostatectomy and novel hormonal treatment will be done according to current recommendations and guidelines in Finland.

Postoperatively, patients will be followed with PSA every six months. Biochemical recurrence will be set at PSA of 0.2 ug/l or higher.

Evaluation of Fapi-pet in Prostate Cancer.

Evaluation of Fapi-pet in Prostate Cancer

Positive predictive value of FAPI-PET on a lesion level using histopathology or confirmatory imaging as ground truth

Positive predictive value of FAPI-PET on a patient level using histopathology or confirmatory imaging as ground truth

To explore and compare the biodistribution and signal level of FAPI-PET and PSMA-PET

To explore the biodistribution and signal level of FAP-PET and PSMA-PET in correlation to reference histology (lesion volume and grade in radical prostatectomy specimen and lymphadenectomy specimen)

To explore the biodistribution and signal level of FAPI-PET and PSMA-PET in correlation to tissue protein levels of:

1. FAP and PSMA
2. Markers of reactive stroma and CAFs
3. Neuregulin-1
4. Androgen receptor signalling pathway

To correlate FAPI-PET and PSMA-PET biodistribution and signal level to:

1. Postoperative serum biomarker levels (e.g., PSA, afos)
2. cfDNA/RNA levels in peripheral blood
3. Urinary exosome status for markers of reactive stroma
4. Biochemical recurrence

University of Helsinki

Helsinki University Central Hospital

Assistant professor

Wolfgang Fendler, MD

Lukas Kessler, MD

Jens Siveke, MD

Nader Hirmas, MD

This is a prospective observational trial investigating correlation with histopathology, positive predictive value, detection rate, reproducibility and impact on clinical management of 68-Ga-FAPI PET/CT or PET/MRI in patients receiving this imaging modality for tumor staging or restaging as part of clinical care.

68-Ga-fibroblast-activation-protein-inhibitors (68-Ga-FAPI) are novel Positron emission tomography (PET) tracers that were recently introduced for the imaging of patients with various cancer diseases. The fibroblast-activation-protein (FAP) is highly expressed in carcinoma-associated fibroblasts (CAFs) in the stroma of various tumor entities. The aim of this registry study is to collect data on FAPI expression, positive predictive value, detection rate, reproducibility and impact on clinical management of 68-Ga-FAPI PET/CT or PET/MRI on patients receiving this imaging modality at initial diagnosis or restaging as part of clinical care.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Application of FAPI and FDG PET Imaging in Patients With Different Types of Cancer	NCT06284070	Cancer		18 Years -	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Application of FAPI and FDG PET Imaging in Patients With Different Types of Cancer	NCT06284070	Cancer		18 Years -	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
A Prospective Cohort Study of 68ga-FAPI-pet-ct Versus FDG-pet-ct for Ovarian Cancer	NCT05824247	Ovarian Cancer	68Ga-FAPI-PET-C...	20 Years - 65 Years	The First Affiliated Hospital of Xiamen University
FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients With Select Solid Tumors (FRONTIER)	NCT05432193	Pancreatic Duct... Colorectal Canc... Esophageal Canc... Melanoma (Skin) Soft Tissue Sar... Head and Neck S... Cholangiocarcin...	[Ga-68]-PNT6555 [Lu-177]-PNT655...	18 Years -	POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
Evaluation of Fapi-pet in Prostate Cancer.	NCT05192694	Prostate Cancer	Computed tomogr...	18 Years - 100 Years	Helsinki University Central Hospital
FAPI-PET for Tumor Detection	NCT04571086	Malignant Neopl...		18 Years -	University Hospital, Essen
FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients With Select Solid Tumors (FRONTIER)	NCT05432193	Pancreatic Duct... Colorectal Canc... Esophageal Canc... Melanoma (Skin) Soft Tissue Sar... Head and Neck S... Cholangiocarcin...	[Ga-68]-PNT6555 [Lu-177]-PNT655...	18 Years -	POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
Application of FAPI and FDG PET Imaging in Patients With Different Types of Cancer	NCT06284070	Cancer		18 Years -	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Evaluation of Fapi-pet in Prostate Cancer.	NCT05192694	Prostate Cancer	Computed tomogr...	18 Years - 100 Years	Helsinki University Central Hospital

Spots Global Cancer Trial Database for fapi

Every month we try and update this database with for fapi cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fapi

Every month we try and update this database with for fapi cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fapi cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.