TARGeted Intraoperative radioTherapy With the INTRABEAM-System as an Advanced Boost in Patients With Breast Cancer - A Quality Control Registry in Germany (TARGIT BQR)
Conditions: Breast Cancer
Sponsor: Universitätsmedizin Mannheim

General application form for the Medical Faculty of Heidelberg University (Ethik-Kommission II ) 
Version 9.0 
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APPLICATION FOR EVALUATION OF A RESEARCH PROJECT 
TO THE MEDICAL ETHICS COMMITTEE II  
of the 
RUPRECHT KARL UNIVERSITY OF HEIDELBERG 
MEDICAL FACULTY MANNHEIM 
MANNHEIM UNIVERSITY HOSPITAL 
- 
This application is suitable for independent studies, epidemiological studies, and MPG 
studies in accordance with MPG §23b.  
The application is not suitable for drug research and MPG studies in accordance with §20 
ff. 
--------------------------------------------------------------------------------------------------------------------------------- 
 
Please note the information on the individually drafted patient information and consent form in the appendix to 
the application, the sample text on the subject of "data protection," and the final check at the end of the 
application form. The application can only be reviewed by the ethics committee if it contains at least the 
standard information. 
 
Ethik-Kommission IIIn accordance with §15 of the Professional Code of Conduct for Physicians in Baden-
Württemberg, I request that the Medical Ethics Committee of Heidelberg University review my study proposal 
described below. 
 
I. GENERAL INFORMATION 
  
 
 
 
 
 
 
 
 
 
 
 
Reception stamp 
 
 
1. 
Date of application:  
 
 
July 31, 2011 
 
2. 
Project name (English title):  
TARGIT-BQR (TARGeted 
                                            Intraoperative RadioTherapy – Boost Quality Control Registry) 
 
3. 
Is this a multicenter study?  
Yes:  X 
No: 
 
4. 
Specify type of study: Quality assurance according to radiation protection guidelines 
 
  
Pilot study? Comparative?  Placebo? Open? Randomized? Single-blind? Double-blind?  
 
5. 
Name and address of the responsible study director in the field of medical EK II:  
 
Prof. Dr. F. Wenz, Clinic for Radiation Therapy & Radiooncology, UMM 
 A clinical study should only be conducted by a qualified person in order to clearly define responsibility. 
 
5.1 
Name and address of the responsible project manager (LKP) in Germany, see 5.1 
  
(applies to multicenter studies whose principal investigator is not based in the area of Medical Ethics Committee II): 
 
5.2 
Responsible investigator:  Prof. Dr. F. Wenz  
 
 
5. 
Names and roles of other investigators:  
 
  
Dr. Elena Blank, Dipl Psych Grit Welzel, Anke Keller (study nurse), data collection, 
            statistical analysis 
 
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General application form for the Medical Faculty of Heidelberg University (Ethik-Kommission II ) 
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6.0 
Medical clinic/clinics or departments or institutes where the project is to be carried 
out: 
 
 
 
Clinic for Radiation Therapy & Radio-Oncology, UMM 
 
 
7. 
Head of clinic or institute:  Prof. Dr. F. Wenz 
 
8.0 
Who is covering the costs of the study (please also indicate partial funding)? Not 
applicable 
  
 
The expense allowance for the Medical Ethics Committee II for the assessment of the 
project will be covered by (provide billing address): (only studies without any financial support 
are free of charge; see also the official fee schedule of the Ethics Committees of Heidelberg University) 
 
9.0 
Has an application with the same content already been submitted to another ethics 
committee  
? 
 
  
No 
 
  
a) If yes, when and where: 
 
  
b) Has a vote already been cast (please enclose a copy): 
 
10.  
For multicenter study applications: 
 
Has a positive vote been obtained from the project manager/study director (LKP) 
responsible for Germany? 
 For multicenter studies, the vote of the responsible project manager/study director (LKP) must be available before the 
application can be assessed by the local ethics committee. 
 
  
Mannheim Medical Ethics Committee as the leading EC 
 
 
II. DESCRIPTION OF THE PROJECT 
 
11. 
Aim of the study (brief outline with the main objectives):  
 
As part of quality assurance in accordance with radiation protection guidelines and X-ray regulations, 
radiation therapists are required to provide regular follow-up care after therapeutic radiation application. As a 
rule, annual follow-up examinations with structured documentation of local control and side effects take place 
for up to 5 years after the end of therapy.  
 
Intraoperative radiotherapy has been performed for breast cancer as an early tumor bed boost for several 
years in accordance with national guidelines (Sautter-Bihl et al: DEGRO practical guidelines for radiotherapy 
of breast cancer. Strahlenther Onkol 2007; 183:661-666). We have already published several articles on the 
safety and toxicity of the procedure (e.g., Wenz F, Welzel G, Blank E, Hermann B, Steil V, Suetterlin M, 
Kraus-Tiefenbacher U: Intraoperative radiotherapy (IORT) as a boost during breast conserving surgery 
(BCS) using low kV X-rays – the first five years of experience with a novel approach. Int J Radiat Oncol Biol 
Phys 77:1309-1314, 2010). 
 
As part of the project, a multicenter study will now be conducted to determine whether the results we have 
achieved can also be achieved in regional healthcare settings. To this end, patients who receive IORT as an 
early tumor bed boost and are treated and followed up in accordance with the guidelines will be prospectively 
registered and documented. For this purpose, pseudonymized data from the other centers will be faxed to 
the registry center in Mannheim and evaluated by us.  
 
 
12. 
Planned start and expected duration of the study: September 1, 2011 
 
13. 
a) Examination of patients  

General application form for the Medical Faculty of Heidelberg University (Ethik-Kommission II ) 
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Number/inpatient:  
 
1000 
  
 
Number/outpatients:  
 
0 
  
 
Patients capable of giving consent 
 
100 
  
 
Patients unable to give consent 0 
 
 
  
b) Examination of test subjects: Not applicable 
 
  
 
Number: 
 
 
14 
Expected duration of the study phase for each patient/subject: 5 years 
 
 
15. 
Age of patients/subjects:  
 
Lower limit: 18 years 
Upper limit:  85 years 
 
 
16. 
What exactly will be done with the patient/subject? 
Detailed description requested. Additional measures that are purely study-related must be clearly 
indicated.  
What is the ratio of the expected benefits of the study to the risks associated with it? 
 
The patient receives standard therapy and follow-up care in accordance with guidelines. No 
additional imaging examinations or blood samples are taken. The standard documentation is faxed 
to us and evaluated by us.  
 
16.1 
Purely study-related measures on patients/subjects that would not otherwise be 
necessary, e.g.: 
 
  
Inpatient stay  
 
 
 
 
No 
  
Blood samples: quantity, number of samples, timing 
No 
  
Bladder catheter 
 
 
 
 
 
 
No 
  
Endoscopy 
 
 
 
 
 
 
 
No 
  
Biopsies, other tissue sampling 
 
 
 
 
No 
  
Lumbar puncture, amount of cerebrospinal fluid 
 
 
 
 
No 
  
X-ray diagnostics 
 
 
 
 
 
 
No 
  
Computed tomography 
 
 
 
 
 
 
No 
  
Magnetic resonance imaging 
 
 
 
 
 
No 
  
Positron emission tomography 
 
 
 
 
No 
  
Radioactive substances/tracers 
 
 
 
 
No 
  
Other invasive measures  
 
 
 
 
No 
 
 
17 
a) Inclusion criteria for patients/subjects:  
 
I.  Are women of childbearing age included? 
 
Yes 
II.  How is conception protection ensured, if applicable: Yes, standard under RT 
III.  Are study participants who are incapable of giving consent included? No 
IV.  Are underage study participants included?  
No 
 
 
  
b) Exclusion criteria for patients/subjects:  
 
I.  Are women of childbearing age excluded?  
No 
II.  Is drug abuse checked and how?  
 
 
No 
III.  Are study participants who are incapable of giving consent excluded? Yes 
 

General application form for the Medical Faculty of Heidelberg University (Ethik-Kommission II ) 
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18. 
Is this a 
 
 trial under the Medical Devices Act (MPG)? 
 
 
No 
 If "yes," then the application must be submitted via DIMBI. 
If there is a CE mark, the intended purpose is identical, and no invasive or stressful 
examinations are carried out for the purposes of the study, § 23b MPG applies and you 
can proceed with this application. 
 Trial to which the X-ray Ordinance applies:  
 
No 
 Experiment to which the Radiation Protection Ordinance applies:  
No 
 Experiment in which genetic information is determined: 
No 
 
 
19. 
Does the research involve human tissue? 
 
No 
  
Has consent been obtained regarding the origin of the tissue? 
  
Is it possible to trace the tissue back to the donor? 
 
20. 
Is this research involving human genetic material? 
 
No 
 
20.1 
Does the data protection concept for this study meet the requirements of the 
European research project "Advanced Clinico Genomic Trials on Cancer (ACGT; 
www.eu.acgt.org or www.privacypeople.org)?" 
 
 
 
Yes 
 
 
 
21 
If the general requirements for clinical trials pursuant to Section 23b MPG are met, 
proof of the CE mark must be provided. 
 
 
Not applicable 
 
22 
If the study 
 
 directly in the interests of patients:  
 
 
 
 
 
No 
 a purely scientific purpose without direct diagnostic and therapeutic value for patients: 
 
 
 
 
 
 
yes 
 the future development of diagnostic and therapeutic procedures:  
yes 
 the acquisition of knowledge about the causes and prognosis of diseases:  
no 
 Gaining insights into specific issues relating to the health status of the population: 
  
 
 
 
 
 
 
 
No 
 Other objectives:  
 
           Yes, comprehensive quality assurance 
 
 
23. 
What typical side effects or complications can be expected? 
 
  
No study-related measures 
 
24. 
Are there any risks for the subjects/patients? No 
 
  
If yes, which ones:  
 
 
25. 
To what extent does the study place an additional burden on subjects/patients? 
 
  
Not applicable, as only additional documentation is required. 
 
 
26. 
Are those involved proficient in the techniques to be used?  
Yes 
 
 
27. 
How can complications be recognized and treated? 
 
Not applicable 
 
27. 
Type and frequency of planned monitoring measures before, during, and  
 after the examination period? 
 
 
 
According to guideline 

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28. 
Is there insurance coverage and for whom (study participants or investigator)? 
 
 
 
Not applicable 
 
Type of insurance:   
  
  
 
28.1 
Where study participants are insured 
  
 
 Subject insurance analogous to the insurance required by law in the German 
Medicines Act (AMG) and Medical Devices Act (MPG) for high-risk projects 
 Coverage must be confirmed and the insurance provider must be based in the Federal Republic of 
Germany. 
 
  
Accident/travel insurance for test subjects/patients; additional or standalone 
The German Medical Association (Ethik-Kommission II ) recommends such insurance for test 
subjects and patients who are examined at other locations or who have to travel for study purposes, 
provided that no other insurance cover exists for this. 
 
28.2 
In which the employees of the University Hospital GmbH (UMM), the Central Institute 
for Mental Health, or the Medical Faculty involved in the study are insured against 
liability claims by study participants (hospital liability insurance – research and teaching 
sector) 
 
28.3 
Other type of insurance, which? 
 
  
Details of the insurance provider:  
 
Name of the insurance provider, full address including telephone and fax number, 
 
Policy number: (Please enclose a copy of the contract)  
 
28.4 
Were the study participants informed of the insurance obligations in the 
patient/subject information, or is a copy of the obligations provided? 
 
 
Not applicable 
 
29 
Is the clinical trial investigator informed about the results of the technical safety 
assessment of the investigational products and the anticipated risks associated with 
the clinical trial? Yes 
 
30 
Have similar or comparable projects already been carried out or are they currently 
being carried out? 
 
  
If so, with what results? 
 
Yes, single-center, see publication, high safety and low 
toxicity rate 
 
31. 
For other studies: 
Are there any doubts as to whether the project complies with the Declaration of Helsinki 
1964, as revised in 1996? 
 
 
 
No 
 
III. Information, explanation, consent, Federal Data Protection Act 
 
The Ethics Committee II of the Medical Faculty of Heidelberg University is of the opinion that 
the processing of the initials and/or full date of birth of a trial participant does not constitute 
pseudonymization of health data within the meaning of Section 2a (2) sentence 2 no. 1 b)-d) 
AMG in conjunction with § 3 (6a) Federal Data Protection Act (BSOS) and is therefore 
unauthorized within the meaning of § 43 (2) No. 1, possibly in conjunction with § 44 (1) BDSG.  
 

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32. 
Does the written subject/patient information presented here correspond to the final 
version (in the case of multicenter studies, the latest and approved version of the ethics 
committee responsible for the LKP)? Yes 
 
33. 
Patient or subject information and the declaration of consent should be written in a 
single document with consecutive page numbers and must be signed by the person 
providing the information and the study participant at the end of the document. 
 
34. 
Is the patient information and consent form marked with a current version number 
and date in the footnote? Yes 
 
35. 
Has an information sheet appropriate for the age group been created for the 
participation of minors? Not applicable 
 
36. 
Has the patient/subject information sufficiently addressed and clearly indicated 
other, alternative treatment methods? 
 
  
Not applicable 
 
37. 
Has the privacy policy been adapted to the individual study conditions? Yes 
 
38. 
Is the section on data protection integrated into the patient/subject information and 
highlighted by a frame or bold print? Yes 
 
39. 
Has the method of pseudonymization been described in an understandable manner 
and does it ensure data protection in accordance with legal requirements (Federal 
Data Protection Act §3, para. 6)?  Is the section on data protection sufficiently detailed 
and understandable to laypersons? Yes 
 
40. 
Who provides clarification? Treating physicians 
 
41. 
If the patient's capacity to make decisions could be called into question, who  
  
objectively assess the patient's capacity to make decisions? Not applicable 
 
42. 
Has consideration been given to the possibility that a legal guardian for the patient 
may be required? Not applicable 
 
 
IV. 
Final Check 
  
  
Does the patient information and consent form meet the standard criteria? 
 
 
 Does the patient information and consent form have a version number? 
 Have the latest proposed changes been implemented and marked (bold, italics, etc., is 
this the final version)? 
 Is it headed with the name of the investigating clinic and the responsible investigator? 
 Is the insurance provider named, including the policy number and full address? 
 Are all topics covered in the patient information? (see sample texts) 
 Does the declaration on confidentiality, data processing, and data protection comply with 
legal requirements? 
 Are all medical terms translated in a way that is understandable to laypeople? 
 Is a contact person for the study participant named and contact details provided in the 
patient information? 
 Has the study participant been expressly made aware of the insurance obligations, if 
applicable? 
 Are the required signatures present? 
 Is the phrase "the patient/subject has received a copy of the patient information and 
consent form" mentioned? 
 Is there a reference to voluntariness, the possibility of withdrawal, etc.? 

General application form for the Medical Faculty of Heidelberg University (Ethik-Kommission II ) 
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 Have the special circumstances of patients who are unable to give consent been taken 
into account? 
 Have the currently valid X-ray regulations and radiation protection regulations been 
observed? 
 
V. Application formalities 
 
This completed application (1 copy in paper form) must also be accompanied by an electronic form 
(CD-ROM) of the application. 
 
Overview of the required documents: 
_ 
  
1. 
Application form 
  
2. 
Test plan – possibly a summary in the application form  
  
3. 
A sample of the written, layman-friendly  
 
 
 
 
 
  
patient/subject information/data protection/consent form. 
   
4. 
Proof of patient/test subject insurance, if required. 
  
5. 
CE certification and material description (only for research projects in 
accordance with Section 23b of the German Medical Devices Act (MPG)). 
  
6. 
Organized electronic form of the application with all documents (CD-ROM). 
 
 
I agree to the research project being carried out at my clinic/institute: 
 
 
 
 
 
 
 
Signature of the responsible study director  
Signature of the head of the clinic/institute 
and name in block letters 
 
 
 
 
and name in block letters 
 
 
 
 
 
____________________________________________________________________________ 
Send these documents to: 
 
Medical Ethik-Kommission II 
Mannheim Medical Faculty 
of Heidelberg University 
Office 
Ms. Songhui Cao / Ms. Alison Gorbey 
Maybachstraße 14 
 
D-68169 Mannheim 
 
...and this is how you can reach us: 
  
 Tel. 
0621- 383 9706/7 
    
  
Fax 
0621-- 383 9710