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Clinical Trials/NCT05160051
NCT05160051
Completed
Phase 2

68Ga-FAPI-46 PET for Imaging of FAP Expressing Cancer: A Single-center Prospective Interventional Single-arm Clinical Trial

University Hospital, Essen1 site in 1 country158 target enrollmentStarted: December 1, 2021Last updated:
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ConditionsTumor, Solid

Overview

Phase
Phase 2
Status
Completed
Sponsor
University Hospital, Essen
Enrollment
158
Locations
1
Primary Endpoint
Positive predictive value (PPV) on a per-region- and per-patient-basis (table 3) of 68Ga-FAPI46 PET for detection of histopathology-FAP-positive tumor lesions, confirmed by histopathology/biopsy (reached for ≥ 75%).
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This study is to explore the safety and tolerability as well as diagnostic accuracy of 68Ga-FAPI-46 for different FAP-expressing tumor entities by PET.

This study does not offer any treatment for patients with FAP-expressing carcinomas; therefore, patients will be offered state of the art therapeutic options. Routine surgery will be performed within 8 weeks after 68Ga-FAPI-46 PET.

Detailed Description

Primary Endpoint:

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

Secondary Endpoints:

  1. Association between 68Ga-FAPI-46 PET uptake intensity and histopathologic FAP expression
  2. Sensitivity and specificity of 68Ga-FAPI-46 PET on a per-patient and per-region-basis for detection of histopathology-FAPpositive tumor lesions confirmed by histopathology/biopsy (separate for regional, extra-regional and distant locations)
  3. Detection rate of 68Ga-FAPI-46 PET versus previous standard imaging on a per-patient and per-region-basis for detection of tumor location, also stratified by tumor maker serum level
  4. Sensitivity and specificity of 68Ga-FAPI-46 PET versus previous standard imaging on a per-patient and per-region-basis for detection of tumor lesions confirmed by combined histopathology/biopsy/follow-up imaging/clinical follow-up reference standard (separate for regional, extra-regional and distant locations)
  5. Impact on management
  6. Inter-reader reproducibility
  7. Safety
  8. Change in staging/prognostic groups

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Proven or suspected tumor types: Breast, Colorectal, Endometrial, Esophageal, Glioma/GMB, Head and neck, Hepatocellular carcinoma, ,Lymphoma, Multiple Myeloma, Neuroendocrine, NSCLC (Non small cell lung cancer), Ovarian, Pancreatic, Prostate, Renal cell carcinoma, Sarcoma, SCLC (Small cell lung cancer), Semimoma, Thyroid, Unknown primary, Other
  • •At initial staging or re-staging of disease
  • •At least one detectable tumor lesion with any diameter \>1 cm
  • •Intended or performed surgery or biopsy of tumor within 8 weeks before or after enrollment
  • •Age ≥18 years
  • •Patient Eastern Cooperative Oncology Group (ECOG) performance status ≤
  • •Women of child bearing potential (WOCBP), defined 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 h before radiopharmaceutical application.

Exclusion Criteria

  • •Patient cannot give consent for the study
  • •Patient cannot lie flat or tolerate 68Ga-FAPI-46 PET imaging
  • •Prior external beam radiation therapy (EBRT) within 3 months of enrollment to tumor lesions intended for surgery or biopsy
  • •Prior chemotherapy, immunotherapy, biologic or targeted oncologic therapy within 3 months of enrollment
  • •Unwillingness or inability to comply with study and follow-up procedures
  • •History of disease or condition that may critically interfere with participation in this study at the discretion of the investigators
  • •Pregnant, lactating, or breast-feeding women
  • •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 patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation 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.

Outcomes

Primary Outcomes

Positive predictive value (PPV) on a per-region- and per-patient-basis (table 3) of 68Ga-FAPI46 PET for detection of histopathology-FAP-positive tumor lesions, confirmed by histopathology/biopsy (reached for ≥ 75%).

Time Frame: within 8 weeks of FAPI-PET scan, when a tumor sample becomes available for immonostaining for FAP

Secondary Outcomes

  • Sensitivity and specificity of FAPI-PET on a per-patient and per-region-basis for detection of histopathology-FAP-positive tumor lesions confirmed by histopathology/biopsy(within 8 weeks of FAPI-PET scan, when a tumor sample becomes available for immonostaining for FAP)
  • Correlation between 68Ga-FAPI-46 PET uptake intensity and histopathologic FAP expression(within 8 weeks of FAPI-PET scan, when a tumor sample becomes available for immonostaining for FAP)
  • Change in staging/prognostic groups per survey of referring physician who was provided with FAPI-PET scan information.(through study completion, an average of 1 year)
  • Detection rate of FAPI-PET versus previous standard imaging on a per-patient and per-region-basis for detection of tumor location, also stratified by tumor maker serum level(up to time point when patient reaches end-of-study criterion (30day, if surgery is performed within 30 days after FAPI-PET or up to 8 weeks, at time of surgery/biopsy))
  • Inter-reader reproducibility: determination of FAPI-PET scan interpretation reliability by three independent evaluators(through study completion, an average of 1 year)
  • Sensitivity and specificity of FAPI-PET vs. previous standard imaging on a per-patient and per-region-basis for detection of tumor lesions confirmed by combined histo/biopsy/FU imaging/clinical FU reference standard(up to time point when patient reaches end-of-study criterion (30 day, if surgery is performed within 30 days after FAPI-PET or up to 8 weeks, at time of surgery/biopsy))
  • Safety (AEs, SAEs, SUSARs)(From signing the ICF until day 30 after FAPI-PET scan)

Investigators

Sponsor
University Hospital, Essen
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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