Tumor, SolidPhase 2NCT05160051
68Ga-FAPI-46 PET for Imaging of FAP Expressing Cancer
A Phase 2 study testing 68Ga-FAPI-46 PET Scan in people with Tumor, Solid, run by University Hospital, Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor, Solid
- What is being tested?
- 68Ga-FAPI-46 PET Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2021to 6 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ≤2.
- 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.
Who cannot join
- 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
Show all 24Show fewer
- 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.
- Bilateral tubal occlusion.
- Combined (estrogen- 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 (IUD) or intrauterine hormone-releasing system (IUS)
- 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 folliclestimulating 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
- 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
- QTcF >470 msec for females and QTcF >450 msec for males on screening electrocardiogram (ECG) or history of congenital long QT syndrome.
- Known or expected hypersensitivity to 68Ga-68-FAPI-46 or any of the relevant excipients.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Nuclear medicine, University hospital Essen
Essen, North Rhine-Westphalia, 45147
About this study
Official title: 68Ga-FAPI-46 PET for Imaging of FAP Expressing Cancer: A Single-center Prospective Interventional Single-arm Clinical Trial
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.
Read the 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:
- Association between 68Ga-FAPI-46 PET uptake intensity and histopathologic FAP expression
- 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)
- 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
- 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)
- Impact on management
- Inter-reader reproducibility
- Safety
- Change in staging/prognostic groups
- Conditions
- Tumor, Solid
- Being tested
- 68Ga-FAPI-46 PET Scan
- Keywords
- radiotracer, PET scan, FAPI-46, 68Ga-radiotracer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI-46 PET ScanDiagnostic test
68Ga-FAPI-46 is a radiotracer that binds with high affinity to Fibroblast Activating Protein (FAP). FAP is physiologically expressed in many tissues during embryonic development, but in adults it is expressed only in the context of wound healing, fibrotic processes, and the stroma of many malignancies. Therefore, the study seeks to validate if 68Ga-FAPI-46 PET could be established as a diagnositc tool to detect solid tumors.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-FAPI-46 PET Scan | Experimental | A single-center prospective interventional single-arm clinical trial. All eligible subjects undergo FAPI-PET Scan Receives: Diagnostic Test: 68Ga-FAPI-46 PET Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: within 8 weeks of FAPI-PET scan, when a tumor sample becomes available for immonostaining for FAP
Secondary outcomes (7)
Correlation between 68Ga-FAPI-46 PET uptake intensity and histopathologic FAP expression
Measured: within 8 weeks of FAPI-PET scan, when a tumor sample becomes available for immonostaining for FAP
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
Measured: within 8 weeks of FAPI-PET scan, when a tumor sample becomes available for immonostaining for FAP
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
Measured: 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)
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
Measured: 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)
Inter-reader reproducibility: determination of FAPI-PET scan interpretation reliability by three independent evaluators
Measured: through study completion, an average of 1 year
Safety (AEs, SAEs, SUSARs)
Measured: From signing the ICF until day 30 after FAPI-PET scan
Change in staging/prognostic groups per survey of referring physician who was provided with FAPI-PET scan information.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start1 Dec 2021
- Primary completion6 Mar 2024
- Study completion6 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tumor, SolidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single application of 68Ga-68-FAPI-46 PET/CT imaging to detect tumour tissue in patients with newly diagnosed or recurrent cancer
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160051
- Sponsor's protocol ID
- FAPI-PET Trial
- Status last verified
- Apr 2024
- First submitted
- 12 Oct 2021
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pabst KM, Weber MM, Laschinsky C, Sandach P, Bartel T, Kuper AT, Kessler L, Trajkovic-Arsic M, Eckstein M, Gilman E, Nader M, Barbato F, Podleska LE, Hadaschik BA, Hamacher R, Kersting D, von Ostau N, von Tresckow B, Kaelberlah HP, Kesch C, Kuemmel S, Reinacher-Schick A, Schuler M, Siveke JT, Grunwald V, Herrmann K, Fendler WP. [68Ga]Ga-FAPI-46 PET accuracy for cancer imaging with histopathology validation: a single-centre, single-arm, interventional, phase 2 trial. Lancet Oncol. 2025 Sep;26(9):1204-1214. doi: 10.1016/S1470-2045(25)00299-2. Epub 2025 Aug 4.
PubMed 40774265Watanabe M, Fendler WP, Grafe H, Hirmas N, Hamacher R, Lanzafame H, Pabst KM, Hautzel H, Aigner C, Kasper S, von Tresckow B, Stuschke M, Kummel S, Lugnier C, Hadaschik B, Grunwald V, Zarrad F, Kersting D, Siveke JT, Herrmann K, Weber M. Head-to-head comparison of 68 Ga-FAPI-46 PET/CT, 18F-FDG PET/CT, and contrast-enhanced CT for the detection of various tumors. Ann Nucl Med. 2025 Mar;39(3):255-265. doi: 10.1007/s12149-024-01993-7. Epub 2024 Oct 23.
PubMed 39443386Watanabe M, Fendler WP, Grafe H, Hirmas N, Hamacher R, Lanzafame H, Pabst KM, Hautzel H, Aigner C, Kasper S, von Tresckow B, Stuschke M, Kummel S, Lugnier C, Hadaschik B, Grunwald V, Zarrad F, Siveke JT, Herrmann K, Weber M. Prognostic Implications of 68Ga-FAPI-46 PET/CT-Derived Parameters on Overall Survival in Various Types of Solid Tumors. J Nucl Med. 2024 Jul 1;65(7):1027-1034. doi: 10.2967/jnumed.123.266981.
PubMed 38782454Hirmas N, Hamacher R, Sraieb M, Kessler L, Pabst KM, Barbato F, Lanzafame H, Kasper S, Nader M, Kesch C, von Tresckow B, Hautzel H, Aigner C, Glas M, Stuschke M, Kummel S, Harter P, Lugnier C, Uhl W, Hadaschik B, Grunwald V, Siveke JT, Herrmann K, Fendler WP. Diagnostic Accuracy of 68Ga-FAPI Versus 18F-FDG PET in Patients with Various Malignancies. J Nucl Med. 2024 Mar 1;65(3):372-378. doi: 10.2967/jnumed.123.266652. Epub 2024 Feb 8.
PubMed 38331453
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-FAPI-46 PET for Imaging of FAP Expressing Cancer: A Single-center Prospective Interventional Single-arm Clinical Trial
- ClinicalTrials.gov ID
- NCT05160051
- Acronym / sponsor ID
- FAPI-PET Trial
- Conditions
- Tumor, Solid
- Keywords
- radiotracer, PET scan, FAPI-46, 68Ga-radiotracer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Association between 68Ga-FAPI-46 PET uptake intensity and histopathologic FAP expression
- 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)
- 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
- 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)
- Impact on management
- Inter-reader reproducibility
- Safety
- Change in staging/prognostic groups
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single application of 68Ga-68-FAPI-46 PET/CT imaging to detect tumour tissue in patients with newly diagnosed or recurrent cancer
| Arm | Type | Receives |
|---|---|---|
| 68Ga-FAPI-46 PET Scan | Experimental | Diagnostic Test: 68Ga-FAPI-46 PET ScanA single-center prospective interventional single-arm clinical trial. All eligible subjects undergo FAPI-PET Scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-FAPI-46 PET Scan68Ga-FAPI-46 is a radiotracer that binds with high affinity to Fibroblast Activating Protein (FAP). FAP is physiologically expressed in many tissues during embryonic development, but in adults it is expressed only in the context of wound healing, fibrotic processes, and the stroma of many malignancies. Therefore, the study seeks to validate if 68Ga-FAPI-46 PET could be established as a diagnositc tool to detect solid tumors. | Diagnostic test | 68Ga-FAPI-46 PET Scan |
Primary outcome
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
7 secondary outcomes
Correlation between 68Ga-FAPI-46 PET uptake intensity and histopathologic FAP expression
Time frame: within 8 weeks of FAPI-PET scan, when a tumor sample becomes available for immonostaining for FAP
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
Time frame: within 8 weeks of FAPI-PET scan, when a tumor sample becomes available for immonostaining for FAP
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
Time frame: 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)
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
Time frame: 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)
Inter-reader reproducibility: determination of FAPI-PET scan interpretation reliability by three independent evaluators
Time frame: through study completion, an average of 1 year
Safety (AEs, SAEs, SUSARs)
Time frame: From signing the ICF until day 30 after FAPI-PET scan
Change in staging/prognostic groups per survey of referring physician who was provided with FAPI-PET scan information.
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Derived from this study: PubMed 40774265Pabst KM, Weber MM, Laschinsky C, Sandach P, Bartel T, Kuper AT, Kessler L, Trajkovic-Arsic M, Eckstein M, Gilman E, Nader M, Barbato F, Podleska LE, Hadaschik BA, Hamacher R, Kersting D, von Ostau N, von Tresckow B, Kaelberlah HP, Kesch C, Kuemmel S, Reinacher-Schick A, Schuler M, Siveke JT, Grunwald V, Herrmann K, Fendler WP. [68Ga]Ga-FAPI-46 PET accuracy for cancer imaging with histopathology validation: a single-centre, single-arm, interventional, phase 2 trial. Lancet Oncol. 2025 Sep;26(9):1204-1214. doi: 10.1016/S1470-2045(25)00299-2. Epub 2025 Aug 4.
- Derived from this study: PubMed 39443386Watanabe M, Fendler WP, Grafe H, Hirmas N, Hamacher R, Lanzafame H, Pabst KM, Hautzel H, Aigner C, Kasper S, von Tresckow B, Stuschke M, Kummel S, Lugnier C, Hadaschik B, Grunwald V, Zarrad F, Kersting D, Siveke JT, Herrmann K, Weber M. Head-to-head comparison of 68 Ga-FAPI-46 PET/CT, 18F-FDG PET/CT, and contrast-enhanced CT for the detection of various tumors. Ann Nucl Med. 2025 Mar;39(3):255-265. doi: 10.1007/s12149-024-01993-7. Epub 2024 Oct 23.
- Derived from this study: PubMed 38782454Watanabe M, Fendler WP, Grafe H, Hirmas N, Hamacher R, Lanzafame H, Pabst KM, Hautzel H, Aigner C, Kasper S, von Tresckow B, Stuschke M, Kummel S, Lugnier C, Hadaschik B, Grunwald V, Zarrad F, Siveke JT, Herrmann K, Weber M. Prognostic Implications of 68Ga-FAPI-46 PET/CT-Derived Parameters on Overall Survival in Various Types of Solid Tumors. J Nucl Med. 2024 Jul 1;65(7):1027-1034. doi: 10.2967/jnumed.123.266981.
- Derived from this study: PubMed 38331453Hirmas N, Hamacher R, Sraieb M, Kessler L, Pabst KM, Barbato F, Lanzafame H, Kasper S, Nader M, Kesch C, von Tresckow B, Hautzel H, Aigner C, Glas M, Stuschke M, Kummel S, Harter P, Lugnier C, Uhl W, Hadaschik B, Grunwald V, Siveke JT, Herrmann K, Fendler WP. Diagnostic Accuracy of 68Ga-FAPI Versus 18F-FDG PET in Patients with Various Malignancies. J Nucl Med. 2024 Mar 1;65(3):372-378. doi: 10.2967/jnumed.123.266652. Epub 2024 Feb 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68Ga-FAPI-46 PET Scan in people with Tumor, Solid, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05160051, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.